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Functional Services Provider (FSP) Consulting Services

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Our Clinical Research Consulting Services are meticulously designed to elevate and enhance your trials from Phase I to Phase II and beyond. Emphasizing a partnership built on successful collaboration, we offer our expertise to biotech companies and pharmaceutical sponsors driving groundbreaking advancements in drug development.

Let’s Build on Success

Did you know: Our Clinical Research Consulting approach is centered on cultivating enduring relationships that grow with your project’s needs. We understand the dynamics of pharmaceutical and biotech companies, especially those with compact teams, and we tailor our services to extend your capabilities without the necessity of expanding your internal staff. Read what they say about us here.

Our belief in partnership-driven success extends beyond Phase 1 trials, aiming to support your project’s growth through the early development phase. Let one of our experts be a part of your team for your next project.

Dr. John Oldenhof

Executive Vice President, Scientific Affairs

Flexible Consulting Roles

Choose from our array of consulting roles tailored to your needs:

Pharmacokinetic (PK) Scientist

Guide your protocol design and support your Phase II study planning.

Statistician

Provide critical analysis and data interpretation to inform decision-making processes.

Clinical Pharmacology (CP) Scientist

Offer expertise in drug action and interaction, enhancing the scientific validity of your studies.

Principal Investigator

Ensure the highest standards of study conduct and study integrity.

Regulatory Strategist

Assistance with regulatory requirements and strategy for IND (Investigational New Drug) application to ensure compliance.

Quality Assurance Specialist

Guidance on quality assurance practices and compliance with Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Manufacturing Practice (GMP) standards.

For small to midsize companies navigating drug development complexities with lean teams, our Clinical Research Consulting Services act as a scalable extension of your workforce. This model of drug development consulting services grants access to a spectrum of expertise as needed, ensuring project momentum and optimal resource utilization.

Services Overview 

Streamlined Consulting Services

  • Scope: Our clinical research consulting services offer flexible and tailored support, providing expert guidance and resources on an as-needed basis.
  • Proposed Roles: Pharmacokinetic Scientist, Statistician, Clinical Pharmacology Scientist, Principal Investigator.
  • Implementation: Structured process for assessing your needs and tailoring our services to your needs.

Functional Service Provider (FSP)

  • Scope: The FSP model offers a comprehensive resourcing solution, allowing for direct involvement of our team members in your projects.
  • Proposed Areas of Service: Clinical Pharmacology Scientist, Pharmacokinetic Scientist, Statistician, Data Management, Medical Writing.
  • Implementation: Customized FSP support based on your project needs, integration of FTE employees into your teams, access to necessary tools and resources.

Phase II Drug Development

  • Scope: Building on our Phase I successes, we offer seamless transition and continued support for Phase II projects.
  • Expertise: Pharmacokinetic Analysis, Statistician Services, Data Managment Services, Trial Mastr FIle Setup & Maintenence, Regulatory SUpport (CTA), Quality Assurance Activiries. 
  • Implementation: Smooth transition from Phase I to Phase II projects, leveraging existing staff and processes that we developed for your first clinical studies.

Holistic Support for Success

Our Scientific and Medical Affairs teams bring together a diverse range of talents across Clinical Pharmacology, Biostatistics, Data Management, Medical Writing, and Regulatory Affairs. This multidisciplinary approach in our clinical research consulting services supports intricate study designs, thorough analysis, and meticulous write-ups, ensuring compliant and successful clinical trials. Additionally, our standalone drug development consulting services offer specialized support in areas like Clinical Trial Data Management and biostatistics, enabling us to deliver precise, project-specific solutions without the need for comprehensive service packages. This allows clients with specific, limited needs to benefit from our expertise without the overhead of broader service engagement. Their deep involvement lays a solid foundation for continuity and insights crucial to subsequent phases.

Unrivalled Expertise in Focus: Sample Scenarios 

Strategic Protocol Development

Imagine you’re at the brink of transitioning your promising compound from preclinical success to human trials. However, the design of your Phase I study poses significant challenges in terms of patient safety and potential efficacy markers. Enter our Principal Investigator (PI), who brings years of experience in clinical trial design.

The PI collaborates with your team to refine the study protocol, suggesting innovative approaches to dosing and patient monitoring that not only ensure participant safety but also maximize the potential to detect early signs of efficacy. With the PI’s guidance, your clinical trial protocol becomes a robust foundation for a successful trial.

Overcoming Recruitment Hurdles

Your Phase II study is pivotal, but patient recruitment is lagging, threatening your timeline and budget. Our Principal Investigator steps in with a deep understanding of patient demographics and study requirements.

Using their network and reputation, the PI helps identify new recruitment channels and refines the inclusion criteria without compromising the scientific integrity of the study. Their hands-on approach not only revitalizes recruitment efforts but also engages the community, ensuring your study meets its enrollment targets ahead of schedule.

Navigating Regulatory Challenges

As your groundbreaking therapy approaches the critical Phase III trials, regulatory scrutiny intensifies. Questions arise from regulatory bodies that could delay the start of your study, requiring detailed scientific and clinical reasoning to address.

Our Principal Investigator takes the lead in crafting a compelling response, drawing upon their extensive experience with regulatory agencies. They articulate the scientific rationale behind your trial design and therapeutic approach, successfully addressing the concerns raised and keeping the project on its intended timeline.

Data Interpretation and Communication

Your clinical trial has generated a vast amount of data, and now you face the daunting task of analysis and interpretation. Our Principal Investigator, with their deep clinical and scientific expertise, plays a crucial role in unraveling the data’s story.

They lead the analysis, identifying key findings and translating complex data into actionable insights. When it comes time to communicate these results to stakeholders, the PI ensures clarity and impact, enhancing the credibility and visibility of your research.

Seamless Integration, Scalable Solutions

Initiating our drug development consulting services requires no process or team expansion. Our existing staff and infrastructure seamlessly integrate with your projects, delivering immediate value. As your needs evolve, we scale to match your clinical research demand. Explore how BioPharma’s early phase strategic cliniclal research services can elevate your projects and drive success in clinical research. Reach out to us to discuss customized solutions aligned with your goals and timelines. Your success is our priority, and we’re committed to being your trusted partner in pharmaceutical innovation.

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View our other Services

Phase 1 & 2a
Data Management
Biometrics/CDISC
Human Abuse Potential
Scientific Affairs
Pharmacokinetics
Bioequivalence & Bioavailability
Bioanalysis
Recruitment