Staff Augmentation Trial Master File (TMF) Management

Staff augmentation is a flexible workforce model where we provide full-time contracted professionals who work exclusively for your organization on a temporary basis. Unlike traditional consulting where advisors may serve multiple clients simultaneously, our staff augmentation consultants operate as specialized contractors that integrate directly into your team—following your processes, reporting to your management, and focusing solely on your priorities. This arrangement gives you immediate access to specialized expertise without the administrative burden, recruitment delays, and long-term commitment of permanent hiring.

Our staff augmentation process follows these key steps:

1. Needs Assessment: We begin with a detailed discussion of your requirements, including technical skills, experience level, project scope, timeline, and any specific certifications or backgrounds needed.
2. Resource Selection: Our recruitment team identifies candidates from our network of thousands of consultants, including hundreds of former FDA personnel, who match your specific requirements. We present only the most qualified candidates (typically 1-2) for your consideration.
3. Interviews and Selection: You interview the presented candidates and select the professional who best fits your needs. There's no obligation to proceed with any candidate who doesn't meet your expectations.
4. Onboarding: Once selected, the consultant is quickly onboarded to your organization. They become integrated into your team, using your systems and following your processes.
5. Management and Support: While you direct the day-to-day activities of the consultant, our account management team provides ongoing support to ensure your satisfaction throughout the engagement.
6. Flexibility: The engagement can be extended, scaled, or concluded based on your evolving needs, with no long-term commitment required.

Staff augmentation offers several key advantages for drug, device, biologic, biotech, and others in the FDA-regulated industries:

• Immediate Access to Expertise: Gain specialized skills right away—without the 3-6+ month recruitment timeline typically required for quality roles.
• Flexibility: Scale your team up or down based on workload fluctuations without the administrative burden of hiring and layoffs.
• Cost Efficiency: Avoid expenses associated with permanent employees, including benefits, training costs, office space, and technology.
• Risk Reduction: Test-drive your position's roles and responsibilities before committing to permanent hires, reducing the risk of misaligned job descriptions.
• Knowledge Transfer: Benefit from best practices and specialized expertise that contracted professionals bring from their experience across multiple organizations.
• Focus on Core Activities: Let your permanent team concentrate on strategic priorities while contracted resources handle specific projects or workload surges.

Here are six recent, real-world scenarios that show how clinical teams have tapped our staff-augmentation model to clear bottlenecks and hit critical milestones:

• A mid-sized oncology sponsor brought in a team of senior CRAs for eight months to tackle a surge of postponed on-site visits after a CRO transition. The team completed 400+ monitoring visits, closed 97 percent of open queries, and enabled a clean database lock three weeks ahead of the statistical-analysis-plan milestone.

• A vaccine developer embedded four start-up specialists and one regulatory project manager to handle EC/IRB submissions, site contracts, and budget negotiations while the internal team focused on protocol amendments. First-patient-in was achieved 47 days sooner than forecast, protecting a critical seasonal-influenza window.

• With an announced BIMO inspection eight weeks away, a biotech firm augmented its staff with a TMF lead and three QC reviewers to audit, reconcile, and remediate 11,000+ documents across three CROs. The inspection closed with zero TMF-related 483 observations, preserving the NDA timeline.
• A CNS sponsor shifting to a decentralized-trial model engaged two contract Clinical Operations Managers for nine months to oversee wearables vendors, eCOA integration, and remote-site training. Protocol deviations dropped 35 percent, and patient-reported-outcome completion climbed to 92 percent within three monitoring cycles.
• An immunology company supplemented its team with one contracted Data-Management Lead and two SDTM programmers for six months to build interim-analysis datasets in parallel with the ongoing study. The adaptive-dose decision was delivered to the DSMB on schedule, avoiding a $2 million extension of the study timeline.

• A small sponsor lacking internal expertise engaged a clinical-trial coordinator and a safety liaison for 12 months to manage DSMB logistics, expedite SUSAR submissions, and maintain global safety-reporting compliance. All safety letters were filed within regulatory deadlines, and the DSMB charter activities ran without delay, keeping the study within its projected burn rate.

• Temporary Gaps: When you need to fill critical positions quickly during transitions, leaves of absence, or unexpected departures.
• Project-Based Needs: When timelines don't justify permanent headcount, such as remediation activities, system implementations, or facility startups.
• Specialized Expertise: When you require specialized skills that aren't needed continuously but are critical for specific phases or projects.
• Headcount Restrictions: When budget constraints or hiring freezes prevent permanent additions despite workload demands.
• Uncertain Duration: When the timeline for resource needs isn't clearly defined, making the flexibility of staff augmentation particularly valuable.
• Skill Validation: When you want to validate job descriptions and responsibilities before committing to permanent hires.

If you're unsure whether staff augmentation is right for your situation, our account managers can help you evaluate your specific needs and recommend the most appropriate resourcing model. We do it all the time. Contact us.

We specialize in the FDA-regulated life science and medtech industries listed below. We also support Contract Development and Manufacturing Organizations (CDMOs), Contract Research Organizations (CROs), and other service providers within these sectors. Our exclusive focus on FDA-regulated industries ensures that our consultants understand the unique regulatory requirements, quality standards, and compliance expectations specific to these sectors. This specialization allows us to provide resources who can contribute effectively from day one, without the learning curve typically associated with generalist staffing firms whose recruiters typically don't come from the industries they're hiring into.

• Pharmaceuticals
  • Rx (Prescription) Drugs
  • Generic Drugs
  • Combination Products
  • Over-the-Counter (OTC) Medications
  • Compounding Drug Products (including 503B facilities)
  • Orphan Drugs (for rare diseases)
  • Active Pharmaceutical Ingredients
  • Radiopharmaceuticals
• Medical Devices/Medtech
  • Diagnostics
  • Surgical Instruments
  • Implantable Devices
  • Wearable Medical Devices
  • Dental Devices
  • Ophthalmic Devices
  • Orthopedic Devices
  • Cardiovascular Devices
  • Laboratory Developed Tests (LDTs)
  • Software as a Medical Device (SaMD)
  • In Vitro Diagnostic Devices (IVDs)
• Biologics
  • Biosimilars
  • Vaccines
  • Blood and Blood Components
  • Allergenic Products
  • Peptides
  • CAR T-Cell Therapies
  • Tissue-Engineered Products
  • Monoclonal Antibodies
  • Cell and Gene Therapy
  • Stem Cell-Based Products
  • Recombinant Therapeutic Proteins

Once your requirements are defined, we typically present qualified candidates within 3-5 business days—often much faster—sometimes virtually immediately. After selection, most consultants can begin within 1-2 weeks, depending on their availability and any onboarding requirements specific to your organization. For urgent needs, we can often accelerate this timeline, particularly for common quality roles.

While our 95% first-time success rate demonstrates our ability to match the right resource to your needs, we understand that not every placement works perfectly. If you're not satisfied with a consultant's performance or fit, we'll work promptly to address your concerns or provide a replacement under our Total Quality Guarantee. Our goal is your complete satisfaction with every placement.

To make our initial conversation as productive as possible and help us identify the perfect resource for your needs, consider preparing the following information:

• Role Description: A brief outline of the position you need to fill, including key responsibilities and deliverables. If you have a formal job description, that's helpful but not required.
• Required Experience: Specific industry experience, technical skills, or regulatory knowledge the ideal candidate should possess.
• Project Scope: For project-based needs, a summary of the project scope, key milestones, and expected timelines.
• Timing Considerations: Your ideal start date and the expected duration of the engagement.
• Location Requirements: Whether the role requires on-site presence (and where), can be performed remotely, or requires a hybrid approach.

Don't worry if you don't have all of this information prepared! Our account managers are skilled at asking the right questions to understand your needs. The more context you can provide initially, the more efficiently we can identify the ideal resource for your specific situation.