FSP/Resourcing: Meeting the Moment with Expert Resources

Clinical trial leaders in small and medium-sized biotech companies regularly find themselves at the intersection of growing requirements, shrinking timelines, and talent shortages. With organizational restructuring and staffing reductions continuing, leaders are acknowledging that strategically realigning their resourcing models can be the difference between meeting milestones or missing deadlines, between submitting timely applications or needing to obtain valid data. They are realizing that augmenting in-house teams on a specific, tailored, and managed basis can be a cost-effective and efficient solution, if applied correctly

Meeting Your Specific Challenges with Options

Forming a partnership with a functional service provider (FSP) that specializes in clinical trial conduct and offers engagement models built on flexibility is key. Deciding what functional activities to complete in-house versus outsourcing and the level of desired management and control are often the first steps in establishing the engagement parameters. As a Science-First global clinical research organization (CRO) and consultancy in our 30th year, Veristat’s FSP team offers clients the delivery of clinical development and regulatory expertise options fully tailored to their needs. Clients have access to difficult-to-find experts dedicated to a specific requirement or function to meet their objectives and timelines. Our resources can support work across many disciplines including biostatistics, programming and data management, regulatory consulting, clinical operations including clinical monitoring, project management, site management, as well as medical affairs/safety, medical/regulatory writing, and pharmacovigilance. Together we establish an integrated project workflow to conduct and complete activities efficiently and smoothly.

Certain clients may need strategic resourcing to manage a specific challenge. Others may require a full- or functional service CRO solution. No matter the engagement model, there are several considerations that we believe foster quality standards likely to promote increased return on a sponsors’ investment and clinical program success, and include:

Confidence and trust: A willingness to identify complex needs quickly and find solutions; a partnership that anticipates future requirements.

Consistent collaboration: Regular interactions to identify, understand and resolve your project challenges.

Discipline: Rigorous, repeatable processes always directed toward solutions.

Transparency: Every action is clear and visible to stakeholders.

Flexibility: The commitment and work ethic to anticipate and adapt to your evolving needs

Key Questions to Ask

Specific to FSP engagements, we have identified key factors that should be part of your considerations before launching your clinical program. Each point should be contemplated within the context of your specific needs.

Level of involvement: To what extent will you be involved in identifying talent? Will you want to review CVs and resumes in detail? Or is the preference to allow the CRO to match job roles with professional resources? Make this decision early.

Your place or theirs: What are the preferences regarding work location, technology infrastructure, and standard operating procedures? Critical points to consider.

Measurement: How will performance be reported and measured? Who will be the keeper of key metrics? Who will report this data? How often? How will it be communicated?

Task management: Who manages the day-to-day tasks? Who monitors and interprets results? How is the work/project plan developed and communicated? You will need a good plan to implement this.

Contract details: How will milestones be established, and deliverables defined? Who will monitor and evaluate the quality of the results? What special considerations are required concerning billable hours or deliverables? How will the billing be organized?

Sustaining Global Delivery Momentum Amidst Flux

As biopharma organizations look to bring their clinical programs to their highest yield, successful leaders have now taken the assembly of a fit-for-purpose resourcing strategy to the next level. Opting for an FSP approach could be the logical choice to fill specific talent gaps across your global delivery model. Alternatively, you may conclude that a hybrid approach— where some services are delivered via an FSP model and other services are deployed in a functional or full-service outsourced format— will get you a higher yield on your invested time, energy, and money.

No matter the final determination of how the gaps in your talent portfolio are filled, one thing is certain: partnering with a clinical research organization that offers a breadth of scientific pedigree, a range of flexible service delivery options, and the capacity to serve as an expert navigator of the clinical development process to help you overcome submission challenges will give you a competitive edge.

Are you ready to take action to arrive at a clinical trial service delivery model that addresses your immediate and future talent needs? Do you have the right strategies in place to build on your existing staffing strengths and hit your milestones? As a reliable partner to biopharma organizations around the world, Veristat can help you take a forward-looking approach to applying the right people, processes, and technologies to arrive at the ideal delivery solution for your clinical program.

Before signing your next contract, talk to Veristat. We will help to maximize your opportunities for commercial success.

For more information, visit: https://www.veristat.com/services/strategic-resourcing

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