OUR VISION

Fulcrum R&D's mission is to empower emerging and midsize biopharmaceutical companies like yours, guiding you with expert precision to uncover tailored solutions at every critical stage of your journey.At the core of our organization lies our industry-leading, multidisciplinary team, the driving force behind every biotech innovation we support. From the careful selection of lead drug candidates to the realization of human clinical proof-of-concepts, our experts provide unwavering guidance and expertise at every stage of drug development.With us by your side, you’ll navigate the complexities of the industry with confidence, knowing that each step forward is supported by a partner who is as invested in your success as you are.

WHAT WE DO

We provide program management, monitoring and support a broad range of drug modalities and development programs, including:- Small Molecules
- Peptides & Proteins
- Antibodies & Drug Conjugates
- Oligonucleotides
- Vaccines
- Cell and Gene TherapiesTherapeutic and Regulatory Programs
- IND- and NDA-enabling studies
- Bioanalytical method development and validation
- Pharmacokinetic (PK) and toxicokinetic (TK) Analysis and Modeling
- Safety pharmacology
- Genetic toxicology
- Carcinogenicity studies
- Developmental and reproductive toxicology (DART)
- Dose range finding and repeat-dose toxicity studies
- Specialized and exploratory toxicology
- Pathology review and interpretationOur subject matter experts provide hands-on leadership and strategic insight to ensure every program progresses efficiently and in alignment with regulatory expectations.

Our program management services include:- site identification and initiation
- contract and budget negotiations
- project monitoring
- data management
- electronic data collection
- PK/TK modeling
- biostatistics
- medical writing

From discovery to IND-enabling studies, FRD delivers agile, science-driven solutions tailored to your pipeline needs.

HOW WE WORK

1. Strategic Planning – We map out preclinical and regulatory milestones.2. Integrated Execution – We manage CRO partnerships, study quality, and budgets.3. Regulatory Engagement – We prepare submissions, communicate with agencies, and monitor feedback.4. Risk Management – We ensure proactive issue-solving at every step to keep programs on track.

WHAT YOU CAN EXPECT FROM US

- Reduce the time needed to initiate projects- Focus on best-of-class provision of specific services- Provide targeted, cost-effective use of experienced professionals- Simplify complex processes with quality measurements- Increase and decrease resources and activity without affecting the internal headcount- Allow sponsors to focus on their core competencies- Manage multiple vendors through a central point of contact

Agile, Cost‑Conscious, and Scientifically Rigorous.