《The FDA Group:现代化临床手术资源指南(英文版)(29页).pdf》由会员分享,可在线阅读,更多相关《The FDA Group:现代化临床手术资源指南(英文版)(29页).pdf(29页珍藏版)》请在三个皮匠报告上搜索。
1、A Modern Guide to Clinical Operations Resourcing|1TheFDAGA Modern Guide to Clinical Operations Resourcing How to Balance Outsourcing and Insourcing Models for Maximum Flexibility,Productivity,and EfficiencyTheFDAG Table of Contents4 Summary7 Introduction and Background9 Challenges and Opportunities
2、in Clinical Operations Resourcing13 Determining the Optimal Resourcing Model or Mix18 Creating a Simple Decision Matrix for Clinical Operations Resourcing20 A Few Key Questions to Consider25 Finding the Right Insourcing Resourcing Partner28 Next StepsA Modern Guide to Clinical Operations Resourcing|
3、2TheFDAGMeet the ContributorMark Shapiro,MA,MBA.Mark Shapiro brings two decades of management consulting and hands-on operational leadership experience for clients in the pharmaceutical,CRO,and biotech business.His expertise is growth strategies,business transformation,and operational excellence wit
4、hin clinical research and clinical development.Specialties:Systems-based solutions to develop and integrate people,processes,and information technology to support clinical research and clinical development.Business analytics and performance optimization.Therapeutic Areas of Expertise:Solid and Hemat
5、ologic Tumor Oncology,Nephrology,Infectious Diseases and Vaccines,Critical Care Medicine,Psychiatry,and Pediatrics.A Modern Guide to Clinical Operations Resourcing|3TheFDAGSummaryFacing an intensely competitive talent market,and growing pressures around productivity and cost,clinical teams are recon
6、figuring their R&D operations and organizational structures to get more done in less time with better outcomes.While full-service outsourcing isnt going anywhere,especially as startups and small players continue to enter the market,companies experiencing rapid growth and those with more extensive R&
7、D functions are moving beyond the“make versus build”or“outsource or not”questions to ask,“what is the best outsourcing,insourcing,or hybrid model for this situation?”The blending of outsourcing and insourcing models is changing the types of scientific talent sponsor teams need and can lead to a stra
8、tegic restructuring within their workforce.More sponsor organizations realize the downsides and vulnerabilities of outsourcing too much,and the risks of losing critical domain expertise to third parties.To guard against that risk,more pharma and biotech companies are bringing some competency in-hous
9、e or deploying a more blended model.While clinical leaders are making these resourcing decisions every day,few have taken the time to closely examine the specific factors that teams should consider when deciding to insource or outsource specific functions.There isnt a one size fits all model.In fact
10、,clinical development is very dynamic,and flexibility is the only common feature of todays resourcing strategies.This white paper explores the advantages and disadvantages of various clinical resourcing models in the current clinical landscape.While deciding on the optimal model for a given project
11、is entirely dependent on the factors at hand,we offer several points to consider when framing the question in context.Think of this paper as a starting point for informed decision-makinga playbook for asking the right general questions at the outset of a project to determine the best path forward.A
12、Modern Guide to Clinical Operations Resourcing|4TheFDAGNeed a reliable insourcing partner with deep clinical recruiting expertise and a global talent network?Lets talk.We help companies fill in-house clinical operations roles and scale their teams as needs fluctuate with new R&D initiatives.Whether
13、you manage clinical operations yourself,contract functions to outsourcing partners,or take a hybrid approach,we have the deep clinical expertise and extensive talent network to fill select roles whenever and wherever they arise.We can fulfill clinical contracted and FTE resource placement needs in a
14、 variety of roles and functions including,but not limited to:Clinical Operations Clinical Project Management Clinical Monitoring Biometrics&Data Management Medical WritingA Modern Guide to Clinical Operations Resourcing|5Connect with us and get the conversation started.Get in touch TheFDAGStaff Augm
15、entationGet contracted full-time consultant(FTC)staffing support and functional outsourcing for specified or open-ended engagement durationsa flexible,convenient alternative to traditional hiring.Fill staffing assignments,bridge gaps,and fill interim and even long-term roles.Contracted resources can
16、 work on-site or off-site as a functional extension of your team.Scale your team as needs change.Fill in-house staffing gaps with perfect-fit talent.Get world-class capability and expertise at a competitive rate.Learn more FTE RecruitmentWe rapidly identify and place FTE candidates in a variety of p
17、ositions and job functions.Our recruiters draw on extensive industry expertise to fully understand your hiring needs and conduct a rigorous identification and screening process to provide a shortlist of highly-qualified candidates,especially in specialized,competitive areas.Get rapid delivery of qua
18、lified candidates.Free up the time required to find and hire internally.Avoid candidate overload.Learn more A Modern Guide to Clinical Operations Resourcing|6A Modern Guide to Clinical Operations Resourcing|7TheFDAGIntroduction&BackgroundLife science companies rely on a highly-skilled workforce of s
19、cientists,researchers,and other specialists to fuel their product pipelines.But as R&D activity accelerates across the world and demands more of a tightening labor market,maintaining a consistent source of human capital has become an enormous challenge.Evidence of an R&D talent crunch has been accum
20、ulating for years.A PwC Health Research Institute report found that clinical executives had more difficulty hiring and were less confident in their ability to access top talent back in 2013.Industry trade group PhRMA expressed concern over a“growing U.S.skills gap”in pharmaceuticals,estimating that
21、two million positions will go unfilled between 2015 and 2025,mostly because of STEM talent shortages.A 2018 survey of 354 life sciences hiring managers and human resources professionals conducted by the Coalition of State Bioscience Institutes found high-value positions like RA,R&D,and clinical rese
22、arch were among the most difficult to fill.Functional Areas with Difficult to Fill PositionsRegulatory Affairs/ComplianceQualityResearch&DevelopmentClinical ResearchProduct and/or Process DevelopmentData AnalyticsEngineeringManufacturingMedical AffairsSource:2018 Life Science Workforce Trends Report
23、,CSBI35%28%28%26%25%21%22%9%16%TheFDAGIntroduction&BackgroundAll of these challenges are compounded by the changing nature of the industry itself.A host of business challenges are pressuring companies to curb expenses and find new efficienciesall as studies become more numerous and complex.Some firm
24、s have found relief through consolidation,using M&A to build and scale in select therapeutic areas.Others are right-sizing their workforces and shifting to new R&D organizational models that challenge traditional talent resourcing strategies.The once pervasive trend toward full-service transactional
25、 project outsourcing,for example,has since given way to more nuanced approaches that incorporate multiple outsourcing and insourcing models to reduce costs and drive efficiencies in the face of growing R&D workloads.In addition to thinking more strategically about how and what they outsource,compani
26、es of all sizes are also making strategic investments in bringing specific competencies in-house,either on contract or permanently.Depending on factors particular to the company,product,and project demands,clinical teams are dialing in their own blend of models to strike the right balance of capabil
27、ity and efficiency from one project to the next.With so much moving so fast,few have stopped to consider what each model and mix of models offer in todays landscape.Even fewer have taken the time to document the processes used to identify the most practical resourcing strategy given the unique deman
28、ds,opportunities,and limitations for a given project.Thats precisely what we seek to do in the subsequent sections of this paper.Drawing on existing research and contributions from clinical subject matter experts who see this process unfold firsthand,we identify and briefly unpack the challenges aro
29、und clinical resourcing before demystifying the current rationale for choosing various outsourced and insourced resourcing models.We then explore some key points to consider when making resourcing decisions in the context of a project.A Modern Guide to Clinical Operations Resourcing|8A Modern Guide
30、to Clinical Operations Resourcing|9TheFDAGChallenges&Opportunities in Clinical Operations ResourcingFor decades,CROs developed some of the most effective and efficient systems and grew to a massive scale,giving them power in the marketplace.More recently,they have worked to recruit some of the indus
31、trys best talent from sponsors,academia,and regulatory agencies.Over time,however,the reliance on full-service CRO engagements has slid into an unhealthy dependence.In-house teams find themselves struggling to manage the activities of their providers without the internal resources to pull work back
32、or surge for time-critical efforts.And despite the heavy and increasing reliance on CROs,sponsors still suffer from long cycle times,high costs,and lower than desirable success rates.Historically,in-house sponsor teams suffered in two key areas.First,lean internal operations meant that sponsors some
33、times lacked the functional expertise to proactively oversee and manage all aspects of outsourced workquietly ceding power and leverage to CROs.This problem is still present today,forcing companies to spend millions of dollars on post-study standardization projects to format and harmonize disparate
34、work products from various CROs.Over-reliance on sponsor program and project managers or procurement for vendor oversight means that subject matter experts at CROs dont get the clear direction on technical questions necessary to standardize across programs.It also means that sponsors may not underst
35、and whether they are getting quality and value on highly technical deliverables.The second issue with lean sponsor operations is the inability to have a credible alternative provider in place.The prospect of“rescuing”an underperforming project from one CRO and moving it to another is very challengin
36、g for a team that is already lean.Internal expertise and capacity can provide a buffer or optionality in those situations.It also can ensure that there are sponsor subject matter experts available to relieve personnel busy managing CRO timelines and budgets.Many recent studies have sought to pin dow
37、n and better characterize the rifts in outsourcing that have prompted companies to rethink their approaches.One such analysis,a 2019 report from Tufts CSDD,concluded that outsourcing practices have widely been seen as“fragmented,”“tactical,”and inviting of the very inefficiencies they were supposed
38、to mitigate.A 2018 study from Pharma IQ looked even deeper into these sentiments,finding that the access to expertise,time,and cost efficiencies afforded by CROs often“come at the cost of duties such as intensive communication management,confidentiality concerns,and regulatory considerations.”A Mode
39、rn Guide to Clinical Operations Resourcing|10TheFDAGThis study also revealed an emerging belief among clinical leaders that some functions may naturally lend themselves to more convenient outsourcing while others are better handledor at least better managed or facilitatedin-house.Among Pharma IQs su
40、rvey respondents from sectors including large pharmaceutical,biotech,and device companies,over half(53%)indicated that they fully outsourced their clinical monitoring function while far fewer reported fully outsourcing statistics,pharmacovigilance,and project management at 1%,8%,and 10%respectfully.
41、Studies like these confirm that companies are evolving their resourcing strategies to balance several outsourcing and insourcing models that play to eachs strengths and offer better functional management of outsourced activities.“Today,its not uncommon for a growing biotech company outsourcing their
42、 biometrics operations to need someone with the domain expertise to manage that outsourced work.The same is true of many other functional areas in clinical operations like safety,data management,and monitoring.Even mid-sized companies often need a few contractors or employees in that department to o
43、versee and coordinate activities across CROs and ensure that work is standardized.Those resourcing investments often pale in comparison to the costs of remediating problems resulting from a project being under-resourced.”MARK SHAPIROLife science companies of all sizes are increasingly recognizing ou
44、tsourcing firms as strategic partners that can work faster and better within a blend of resourcing models that utilize in-house domain experts and external resources.The Tufts CSDD report referenced earlier found that firms now often use various models for singular tasks,functions,programs,and full-
45、service arrangements.42%of firms surveyed reported“routinely using”a staff augmentation model for clinical resourcing,for example,while 56%and 77%reported using FSPs and full-service outsourcing,respectively.As these findings validate,hybrid approaches are affording clinical teams the flexibility th
46、at has become advantageous or even necessary for conducting complex studies at the efficiencies needed to keep pace and stay competitive.In practice,this often materializes as an intermediate layer of contracted or permanent functional experts Challenges&Opportunities in Clinical Operations Resourci
47、ngA Modern Guide to Clinical Operations Resourcing|11TheFDAGwith the domain expertise and firsthand experience to oversee and manage CROs more effectively.In some cases,this“functional insourcing”model is scaled up to bring entire functions in-house and under the companys control,either through flex
48、ible staff augmentation(full-time contractors and consultants)or direct hiring(FTEs).This approach offers unique advantages for companies of all sizes.For smaller organizations engaged in project-based outsourcing,filling functional leadership roles with expert insourced contractors and consultants
49、enables broad flexibility,low overhead,and the ability to test particular professionals for possible long-term management and oversight positions if and when permanent needs arise.These functional leaders can also play a pivotal role as hiring managers when larger groups need to be staffed with spec
50、ific skill sets.Larger companies can scale this concept up to create an efficient mix of outsourced and insourced FSPs.In situations where a group of internal resources is preferred over an outsourced group,multiple contractors and consultants can be brought in to form an internal functional departm
51、ent that offers the flexibility of contracted service with the advantage of internal control and aligned incentives.With the right insourced resourcing partnerone that combines reliable clinical recruiting expertise with a deep pool of talent,companies can lift the burden on HR and more quickly reso
52、urce their projects as needs fluctuate.“In project-based outsourcing,youre seeing this layer of contractors,consultants,and sometimes full-time staff who are managing the CRO with a high degree of functional expertise.A Contract Project Manager or Contract Clinical Operations Manager will be functio
53、n-specific and ingrained as an extension of the company.For mid-sized or larger companies accustomed to outsourcing and interested in retaining a healthier level of functional expertise internally,functionally insourcing a department with a group of contractors can provide the leverage needed to reg
54、ain balance in the relationshiplikely reducing change orders in the process.In some cases,the question of whether or not an FSPs team will genuinely perform like theyre your people is a critical one.Insourcing a function can be an antidote to that risk.”MARK SHAPIROChallenges&Opportunities in Clinic
55、al Operations ResourcingTheFDAGThe opportunity to lessen the reliance on CROs is particularly advantageous as R&D workloads grow and protocols get more complex.As many clinical leaders have realized,the more reliant a company is on its CROs,the more critical it is that those overseeing them have the
56、 domain expertise to effectively communicate details,set standards and expectations,and gauge the work being done.“If you dont have someone who knows enough about the domain on your side of those relationships,its very likely youll end up spending more and getting less.”MARK SHAPIRORegardless of how
57、 much or how little its implemented,a functional insourcing strategy may also dovetail with steps companies are already taking to insource the technological and system-specific ownership of clinical projectsa trend that has emerged industry-wide.“Mid-sized and larger companies are insourcing more of
58、 their clinical technology;mandating CROs use their systems for better efficiency and control.”MARK SHAPIROAs companies continue to explore hybrid clinical operations models that balance the benefits of insourcing and outsourcing,an important question arises:What factors should one consider when sel
59、ecting a model or mix of models based on their relative advantages and disadvantages in the context of a particular project?Challenges&Opportunities in Clinical Operations ResourcingA Modern Guide to Clinical Operations Resourcing|12A Modern Guide to Clinical Operations Resourcing|13TheFDAGDetermini
60、ng the Optimal Resourcing Model or MixSo,what goes into the decision to use a model or mixand what balance to strike to make trial conduct faster,less expensive,and less burdensome?Familiarity bias is often the first significant factor.Its natural to rely on what we already know when making decision
61、s for the future.But especially in this context,where traditional models may be ripe for disruption,its all the more important to acknowledge and try to set aside the familiar and comfortable to openly consider new and better ways to work.The other major factor is the project itself;expressly,the ty
62、pe and volume of functional activities involved,protocol complexity,existing competencies,and site locations,just to name a few.Given the extreme variety in these demands from product to product or study to study,this requires a diligent,honest evaluation of the details against each resourcing model
63、s relative strengths and weaknesses.A study that aligns well with a companys existing therapeutic area and internal expertise may lend itself well to functional insourcing via contracted full-time contractor/consultant(FTC)staff augmentation.By contrast,if a new or less developed function is require
64、d to support a more novel study outside of core competencies,outsourced FSPs will be optimal.In a third case,a company pursuing an indication that is wholly new to which there is no internal knowledge or capability may likely be best suited to outsource most or all of the project to a full-service C
65、RO,but also require functional leadership with the domain expertise to oversee and harmonize that work.In these cases,its important to have sponsor representatives whose role is to become the internal subject matter expert and absorb knowledge and expertise from providers to maximize the sponsors li
66、kelihood of success.In the latter two cases,it is important to recognize that a sponsor runs the risk of paying CROs to become experts in the domain that the sponsor needs to be an expert.Recognizing and managing that risk is important for long-term program success.Its okay for the CRO to know more
67、about an area than the sponsor on the first study or two,but later in the program,the sponsor should have equal or greater expertise.Below,weve taken these broad considerations a step further to contextualize the features,advantages,and disadvantages of each model according to a projects needs.TheFD
68、AGRelative Strengths and WeaknessesOften,the bulk of contracted R&D services falls to non-core activities while an internal team is built to manage high-value and highly-sensitive functions.Determining the details of what work falls where often starts by evaluating the timeline goals and relative le
69、vel of control required for each component of the project.The following general criteria can be instructive for making high-level strategic decisions about the best way to resource a project.Determining the Optimal Resourcing Model or MixOutsourcing(CROs,CDMOs,and FSPs)Less complex sample/results wo
70、rk Relatively simple,well-defined,and established workflows Access to novel subject matter expertise Opportunities to gain from highly-optimized processes,systems,and SOPs Less time-sensitive resultsInsourcing(Staff Augmentation&Full-Time Employees)A greater degree of control,using internal quality
71、systems and protocols IP protection through internal oversight Immediate access to results Reduced time managing third parties Optimization of excess laboratory space Improved and timely communication of project deliverables More granular,resource-specific flexibilityA Modern Guide to Clinical Opera
72、tions Resourcing|14TheFDAGGenerally,the less control neededand the less that IP and speed are driving factors for successthe better the fit for outsourcing.Conversely,insourcing can be advantageous in projects requiring greater relative control,mitigating IP risks,and in some cases,accomplishing goa
73、ls in shorter cycles.The following chart attempts to break out the critical factors to consider across several specific outsourced and insourced models.These traits are by no means exhaustive or universal but offer a generic lens to view possible best paths forward when dissecting clinical projects
74、more granularly.Determining the Optimal Resourcing Model or MixContinued Resourcing ModelFull-Service Outsourcing Most or all study tasks are outsourced Project/study management is outsourced The study is conducted according to the vendors processes,systems,and SOPs Typically not fully staffed by de
75、dicated FTEs Contracts are often based on milestonesAdvantages Reduces task-specific management and coordination burden Cohesive integration of multiple services Enables innovation into novel areasDisadvantages Possible management and oversight overload negate cost and resource savings Unwieldy cont
76、ract management slows admins Often inefficient across multiple studiesCharacteristicsAdvantages&Disadvantages Companies outsource the entire function(e.g.,data management,drug safety,clinical monitoring,etc.)Often utilizes the vendors processes,systems,and SOPs Contracts are often arranged by unit o
77、r function Usually not 100%dedicated FTEsAdvantages Better incentive alignment around innovation May include volume discounting Opportunities for process improvement across projectsDisadvantages More than one FSP can significantly complicate process handoffs and create risks Vendor coordination can
78、heighten management burdens Functional Service Provision (FSP)A Modern Guide to Clinical Operations Resourcing|15TheFDAGDetermining the Optimal Resourcing Model or MixResourcing ModelStaff Augmentation(Full-Time In-House Contractors/Consultants)FTE Recruitment Search/staffing partner supplements cli
79、ent staff projects managed internally,including facilitation with outsourced vendors projects Often uses client processes,systems,and SOPs Resources are contracted via full-time equivalency(FTE)May offer on-site or remote resourcing Search/staffing partner supplements client staff projects managed i
80、nternally,including facilitation with outsourced vendors projects Always uses client processes,systems,and SOPs Resources are brought on as full-time employees May offer on-site or remote resourcingAdvantages The requirement to use client processes systems,and SOPs makes it easy to scale up vendors
81、without additional burden A single staff augmentation partnerand even a single contractcan be used to manage multiple projects Company keeps full control over project Access to 100%dedicated FTEs without traditional hiring overhead Can structure contracts to scale resources up and down as needed Dee
82、p clinical recruiting expertise reduces HR burden and riskDisadvantages Possible co-employment risks Less built-in incentive to innovate IT and training can carry additional onboarding burdenAdvantages The requirement to use client processes,systems,and SOPs makes it easy to scale up vendors without
83、 additional burden High incentive to innovate A single recruitment partner can be used to resource multiple long-term projects Company keeps full control over the project Hiring managers can directly source staff via clinical recruiting partner Rapid identification and placement in competitive roles
84、 and functions Deep clinical recruiting expertise reduces HR burden and riskDisadvantages Overhead and payroll costs IT and training can carry additional onboarding burden Requires long-term functional needsCharacteristicsAdvantages&DisadvantagesA Modern Guide to Clinical Operations Resourcing|16A M
85、odern Guide to Clinical Operations Resourcing|17TheFDAGBesides considering the strengths and weaknesses of one or multiple resourcing models qualitatively,looking back on performance and quality metrics can help inform decisions with hard data.In addition to improving processes,analyzing KPIs and KQ
86、Is can also reveal opportunities to enhance broader decisions about which resourcing model or blend of models will best fit a project based on prior experience.For example,slow turnaround times observed from a fully-outsourced project may indicate that a companys internal systems and SOPs may be bet
87、ter suited for greater speed.In this case,some or all of the impacted functions may be transitioned away from a CRO and brought in-house,whether by augmenting staff with full-time contractors for a set period or bringing on an FTE for long-term needs.Determining the Optimal Resourcing Model or MixTh
88、eFDAGCreating a Simple Decision Matrix for Clinical Operations ResourcingNo matter how much a company stands to gain from enhancing its resourcing strategy,securing those advantages requires a resourcing process that accommodates change.Perhaps more importantly than confirming an industry-wide shift
89、 in how clinical projects are resourced,the Tufts CSDD report referenced earlier concluded that only a third of clinical leaders say their resourcing processes are well-established.Even fewerjust one fifthdescribe their processes as highly effective.A simple decision matrix can help logically arrive
90、 at the best decisions around outsourcing and insourcing.Each of the unique activities is rated for strategic importance and their contribution to operational performance.Functions or more granular function-specific activities can be placed in each quadrant and resourced accordingly.Its important to
91、 note that this exercise is not thoroughly instructive for decision-making but rather a helpful starting point.Form a Strategic AllianceRetainOutsourceEliminateHIGHStrategic ImportanceContribution to Operational PerformanceLOWLOWHIGHA Modern Guide to Clinical Operations Resourcing|18A Modern Guide t
92、o Clinical Operations Resourcing|19TheFDAGFSP These tasks are essential for successful operational performance,but have low strategic value.An FSP,either outsourced or insourced,should be sought to achieve high efficiencies at relatively little risk.Full-Service OutsourcingTasks that are not strateg
93、ically important and dont make a significant contribution to operational performance need the least oversight and management,and benefit the most from outsourcing.Creating a Simple Decision Matrix for Clinical Operations ResourcingStrategic Partnership These activities are strategically essential bu
94、t contribute little to operational performance.Outsourcing is likely optimal but requires close oversight from a domain expert.InsourceThese tasks are strategically important and have a significant impact on operational performance.Consider retaining these tasks in-house to keep the maximum level of
95、 control.TheFDAGA Few Key Questions to Consider Whether creating a formal decision matrix or planning resources another way,the following questions can help sharpen decision-making at the outset of a project.1.How well are outsourced activities typically being coordinated?If multiple outsourced part
96、ners are conducting work,there is very often an opportunity to save time and money by establishing an internal oversight function to proactively harmonize those work products by establishing and enforcing standards.Closely examine past project metrics to identify possible opportunities where greater
97、 domain expertise could make work more efficient and proactive.2.Whos paying for expertise,and whos benefiting from it?Its not uncommon for companies engaged in project-based outsourcing(typically small and mid-sized organizations)to pay a CRO to become an expert in an area without absorbing those c
98、ompetencies themselves.When knowledge gained by experience isnt retained,companies become overly reliant on CROs whose personnel may not be available to apply that experience to benefit future projects.A Modern Guide to Clinical Operations Resourcing|20“Especially competitive,complex or very niche a
99、reas,its really important to have somebody from the sponsor side participating in all those relationship activities.This way,even if a CRO is taking on all the work themselves,theres someone from the sponsor receiving that information by being present in key calls and meetings with investigators.Sit
100、es and investigators value those direct relationships with sponsors.”MARK SHAPIROTheFDAG“We often advise small and mid-sized pharma companies that if theyre doing purely project-based outsourcing,its easy to find yourself spending a lot of money to train people up at the CRO to be experts in what yo
101、ure doing only to end up paying a huge opportunity cost in not owning that competency.They lose that organizational memory from one project to the next.If all of that information is owned by the CRO,which may rotate those people onto other projects,a company can find themselves with risks and costly
102、 rework.That can pertain to clinical operations,statistics,or any other functional area.”MARK SHAPIRO3.Are your CROs building relationships with investigators at your expense?Many companies realize they need to invest in establishing relationships with investigators that are critical to their succes
103、s,but end up outsourcing those relationships to the CRO.This can make a company dangerously reliant on those particular people for future studies,who,again,might not be available in the future for a myriad of reasons.A Few Key Questions to ConsiderA Modern Guide to Clinical Operations Resourcing|21T
104、heFDAGA Few Key Questions to Consider4.Could insourcing more flexibly scale to meet changing needs from one phase to the next?While not necessarily tied to clinical research phases,a product scaling exercise may reveal a need or strong advantage in having the flexibility afforded by functional insou
105、rcing.If an internal data management team was preferred for a project,for example,starting by insourcing a data management leader and establishing trust in them at the outset of a project could serve as the stepping stone for scaling up resources to more functional hybrid approach later on.“When thi
106、nking about scaling resources throughout a project,a company may have one insourced functional leader overseeing a CRO in Phase 1.This person is both managing and overseeing the CRO and learning along with them.In Phase 2,the company might consider scaling up its internal expertise if needs emerge a
107、nd just easily shrink that contingent workforce back down in Phase 3.This kind of functional insourcing gives you the chance to test resources and scale your program once youre confident in that leadership.”MARK SHAPIROA Modern Guide to Clinical Operations Resourcing|22A Few Key Questions to Conside
108、rTheFDAG5.Are you experiencing any outsourcing“red-flags”to which insourcing offers a solution?Insourcing is by no means an antidote to every outsourcing issue,but there are a few questions that often signal opportunities to invest in internal expertise.These include:Frequent change orders or diffic
109、ulty evaluating the merits of a change order Difficulty in coordinating details with outsourced partners Slower than expected study progress Budget overruns Chronic dissatisfaction in certain functions Sponsor teams receiving an overwhelming amount of work products from a CRO for review and sign-off
110、(and thereby taking on responsibility for delays)“If a company struggles to answer a CROs questions,that can indicate an internal gap that needs to be filled.Similarly,if a CRO presents a question they feel is important enough to ask,which does not inspire a strong answer,that can also indicate a de
111、ficiency in a functional domain.Difficulties in evaluating the scope or effectiveness of change orders are another big red flag.Id also add slower than expected study progress.Sometimes that can indicate a sponsor struggling to understand some of the clinical operations nuances well enough to establ
112、ish realistic expectations.Slow enrollment,in this case,might stem from a poorly-written protocol rather than a fault of the CRO.”MARK SHAPIROA Modern Guide to Clinical Operations Resourcing|23Key Questions at a Glance“Which model or hybrid approach will get our project done on time and on budget wh
113、ile balancing quality,speed,and cost?”“Are we managing our contracted relationships with adequate,consistent oversight,and regular interaction?”“If we add more outsourcing vendors or outsource more functional work,can we keep up with it all?At what point do internal resources need to scale to accomm
114、odate this?”“Are we retaining the competencies were paying for via outsourced activities?“How could more functional domain expertise improve outsourced work products proactively?”“How could a functional insourcing strategy scale by phase to make life easier for everyone?”TheFDAGA Modern Guide to Cli
115、nical Operations Resourcing|24A Modern Guide to Clinical Operations Resourcing|25TheFDAGFinding the Right Insourced Resourcing Partner As many sectors of the life science industry continue to see dramatic growth,recruiting and retaining highly skilled professionals from a talent pool thats strugglin
116、g to keep up has become an enormous challenge.Todays hiring managers need to be able to scale staff up or down rapidly as project demands fluctuatea never-ending balancing act between managing current resources and planning for future staffing needs.These pressures have led companies to embrace the
117、contingent workforce;highly-skilled individuals with expertise in rare and competitive fields who contract with organizations on a temporary basis.As firms are finding,this model often better reflects cyclical or project-based demand while infusing staff and systems with best practices gleaned from
118、a variety of experiences.But building and managing a contingent workforce can demand significant time and energy without the right resourcing partnerone that can take on the intensive work of finding talent and qualifying candidates around precise requirements.Here,we explain three useful tips when
119、looking for a life science resourcing partner that can help you find exactly who you need,when and where you need them.1.Find your niche.Are they generalists,or do they live and breathe life science?Staffing and recruitment firms that work across a variety of industries often dilute their effectiven
120、ess in each one.The core issue here is that recruiters within these firms are often generalists themselves.Unlike a niche firm,whose recruiters must bring deep industry-specific experience to be successful,generalists often dont have the firsthand subject matter expertise to understand and articulat
121、e the fine points about the roles and functions that guide their search and selection process.TheFDAGWithout the expertise to make their clients lives easier by narrowing 10 to 15 resumes down to five or fewer,generalists often cant avoid the cliche of throwing things against a wall to see what stic
122、ks.If a qualified candidate is even in the stack they provide,its now up to the client to spend the time and energy selecting a winner.Here at The FDA Group,for example,our recruiters and project managers come from the world they hire into each day.Unlike larger firms,were armed with firsthand exper
123、ience working in the roles where the subtle details make all the differenceaccelerating the process of finding great talent.2.Ask about their search process.How do they identify and pre-qualify candidates to make your life easier?Especially in specialized life science roles,a resourcing firms job is
124、 to identify genuinely perfect-fit talentnot simply pass a stack of resumes back.Investigate how the firm finds and selects the resources they deliver as candidates to ensure theyre more than just a job board.What methods do they use to apply your requirements to identify potential candidates?Equall
125、y,if not more importantly:how do they sift through that group and work it down to a shortlist or even just one extremely qualified candidate you can be confident in?Using ourselves as the example again,we have an extensive network of resources with established consulting agreementssome of whom are f
126、ormer FDA staff with intimate knowledge of requirements and expectations.If the perfect resource isnt found there for some reason,we immediately move to an active channel to source from many thousands more in locations all around the world,most of whom are not listed on job boards or other channels
127、utilized by HR departments.A few simple questions can go a long way in locating an effective resourcing partner:Finding the Right Insourced Resourcing PartnerA Modern Guide to Clinical Operations Resourcing|26TheFDAG“Do they work with talent sourcing partners in other countries to secure offshore re
128、sources?”“Are the recruiters tasked with finding a particular skillset still finding their stride professionally?”“Do they tout special software for identifying candidates?”Be wary.These tools are often just flashy crutches to distract from lackluster recruiting skills.As of now,no magic tooleven wi
129、th AIcan outperform an experienced resourcing professional who can discern soft skills through subtle,often intangible indicators.“Do they genuinely know the industry terms theyre working with?”Finding the Right Insourced Resourcing Partner3.Gauge their experience level.Do they have what it takes to
130、 fill specialized functional roles on your team?Experience level often ties in closely to generalist versus niche resourcing firms.This is a simple,but crucial point that often flies under the radar only to result in a messy stack of candidates that might be far from what you actually need.More resu
131、mes dont mean better candidates.“Will this firm push the real work back onto me by showing up with ten or more candidates?Or is this a firm thats so effective I can check their first one or two top choices and move forward without delay?”“How do they identify candidates?Do they have a bench of talen
132、t and active channels?Or do they grab a pre-packaged template and blast it out to LinkedIn?”A Modern Guide to Clinical Operations Resourcing|27TheFDAGWe connect you to top clinical operations talent,wherever and whenever you need them.Need to fill select clinical operations roles in-house?We rapidly
133、 identify qualified consultants,candidates,and contractors and connect you to them through the optimal workforce model.Whether you need to fill a single role or multiple roles on your clinical team,we connect you to professionals with experience and expertise across all phases,therapeutic areas,and
134、locations to augment and scale your in-house clinical operations team through contracted staff augmentation or a direct-hire arrangement.We typically serve as a resourcing partner for companies that have brought or are bringing some or all of their clinical operations function in-house and are looki
135、ng to fill select roles as needs fluctuate with new R&D initiatives.Whether you manage clinical operations yourself,contract some functions to a CRO or FSP,or take a combined approach,we have the deep clinical expertise and large talent network to fill select roles whenever and wherever they arise.A
136、 Modern Guide to Clinical Operations Resourcing|28A Modern Guide to Clinical Operations Resourcing|29TheFDAGLearn more and connect with us.Get in touch Staff Augmentation:Get contracted full-time consultant(FTC)staffing support and functional outsourcing for specified or open-ended engagement durati
137、onsa flexible,convenient alternative to traditional hiring.FTE Recruitment:We recruit FTE candidates with the experience,skills,and background to fulfill a variety of critical roles and functions that have become difficult to fill in a tightening labor market.Clinical Operations,Project Management&M
138、onitoringBiometrics&Data ManagementMedical Writing Clinical Research Associate Clinical Research Coordinator Clinical Research Scientist Clinical Trial Lead Clinical Trial Associate Project Manager Clinical Program Manager Technical Writer Clinical Data Associate Clinical Data Manager Clinical Data Coordinator Biostatistician Clinical Programmer SAS/Statistical Programmer Medical Writer Medical CommunicationsWe can fulfill clinical contracted and direct hire resource placement needs in a variety of roles and functions including,but not limited to:Next Steps