Clinical Development Strategy, Planning & Operations
We help biotech and pharmaceutical companies advance their clinical programs with the hands-on support of experienced industry operators. Our consultants have held CMO, VP Clinical, and Medical Director roles. They have filed INDs, designed pivotal trials, sat in FDA meetings, and guided products through regulatory approval.
Alacrita's core team draws on 150+ clinical development consultants with backgrounds spanning oncology, rare diseases, immunology, CNS, fibrosis, and more. These are former industry executives with an average of 20+ years experience who have managed clinical programs, presented to boards, and navigated the regulatory process firsthand. They understand both the science and the operational realities of getting drugs to patients.
We work with biotech and pharmaceutical companies at all stages, as well as life science investors conducting clinical due diligence and academic institutions seeking to advance promising therapeutics. Our consultants have experience with FDA, EMA, and other major regulatory authorities, supporting programs in both the US and Europe. Whether you need strategic guidance on indication selection, hands-on protocol development, interim medical leadership, or support navigating regulatory interactions, we assemble the right team for your program's specific needs.
Consultants
Experience
Areas
Modalities
For Virtual and Lean Biotechs
Running clinical development without a full internal team? We support virtual biotechs by providing fractional and interim leadership, hands-on execution of development activities, and the coordination to keep programs moving. Our consultants can serve as your clinical development function, integrating seamlessly into your organization while you focus on building your company. You get the capabilities of an established clinical organization without the fixed overhead.
We work with companies at all stages, but we're particularly well-suited for biotechs at critical inflection points: approaching IND submission, transitioning from Phase I to pivotal trials, preparing for financing, or navigating an unexpected leadership gap. Our model delivers the most value when you need experienced operators who can step in and execute, not just advise.
Why Alacrita
Our Model
Alacrita combines a senior core team with a network of 350+ specialist consultants across 29 functional disciplines. This structure allows us to provide precisely relevant expertise for each engagement. Unlike staffing agencies that make introductions and step back, or expert networks that provide hour-long calls, we take responsibility for delivery throughout the engagement. Your contract is with Alacrita. We manage quality, review deliverables, and remain accountable for results. Every consultant in our network is a former industry operator who has held positions in biotech and pharma companies, not a career consultant.
Integrated Support
Whether working directly on your team or on a project basis, our consultants can write your protocols, prepare your FDA briefing documents, manage your CRO relationships, and participate in your team meetings. We work as an extension of your organization, at whatever level of involvement your program requires.
Industry Operators
Our clinical consultants have held CMO, VP Clinical, and Medical Director roles at pharma and biotech companies. They have managed trials, presented to boards, and navigated regulatory interactions. They understand the operational realities of drug development because they have lived them.
Alacrita Accountability
Your contract is with Alacrita, not with an individual consultant. We manage engagements from kickoff through delivery, review work product before it reaches you, and remain accountable for results. If circumstances change or a consultant becomes unavailable, we handle it.
Right-Sized Teams
We match the expertise your program needs, whether that's a single senior medical advisor for a month or a clinical development team for two years. We can scale up or down as your program evolves.
In one engagement, our consultant stepped in as interim medical director five months before a planned MAA submission, after the internal medical director and key team members unexpectedly left. Our team finalized study reports, wrote the clinical overview and SmPC, prepared an Orphan Drug Designation application (which was granted), responded to rapporteur questions including new statistical analyses, and represented the company in regulatory agency meetings. The product was successfully steered through European regulatory approval.
Programs we have supported have advanced through IND submissions, achieved expedited designations including orphan drug status, and progressed through regulatory approval in both the US and Europe.
Services Provided
Clinical Development Strategy & Planning
Clinical Operations
Regulatory Strategy & Interactions
Our regulatory consultants include former FDA and EMA reviewers with firsthand knowledge of how agencies evaluate submissions and what triggers additional scrutiny. We can help you define the optimal regulatory pathway, prepare meeting packages, and navigate expedited programs.
How We Engage
We structure engagements around your needs and adjust as your program evolves. Some clients engage us for a specific deliverable - a clinical development plan, a regulatory pathway assessment, or FDA meeting preparation. Others bring in a consultant as an embedded team member for months or years, attending meetings, owning workstreams, and providing continuity. For companies that need executive-level leadership, we provide interim or fractional CMOs who can step in and contribute immediately.
Many engagements evolve over time. A regulatory strategist might support a submission, then transition into an interim VP Regulatory role. An interim CMO engaged during an executive search might stay on as a fractional advisor after a permanent hire is made. We can scale up or down as your needs change.
Expertise & Coverage
Our clinical development consultants span 22 disease areas and 18 product modalities. These are experienced operators who have led programs from early development through registration. When you engage us, we match consultants with direct experience in your indication and modality.
Therapeutic Area Depth
Our consultants are not generalists. In oncology, our network includes former pharma CMOs, medical directors who have led pivotal trials in both solid tumors and hematologic malignancies, and specialists in immuno-oncology and targeted therapies. In rare diseases, we have consultants who have navigated orphan drug designations, natural history studies, and the unique regulatory and commercial challenges of small patient populations. In CNS, fibrosis, immunology, and other therapeutic areas, we draw on consultants who have spent their careers developing drugs in these specific fields.
Clinical development expertise by product modality
+Clinical development expertise by disease area
+Interim & Fractional Chief Medical Officer
For biotech companies that need CMO-level medical leadership, whether during an executive search, a critical development phase, or on an ongoing fractional basis, Alacrita provides experienced physician executives who can step into the role and contribute immediately. Our interim and fractional CMOs have supported companies through multi-year engagements, contributed to successful financing rounds, and guided programs through regulatory submissions.
Executive-Level Medical Leadership
Our interim and fractional CMOs are physician executives who have held full-time CMO and VP Clinical roles at pharma and biotech companies. They have led global development programs and represented companies to regulators, investors, and boards. One example: a board-certified gastroenterologist/hepatologist who previously served as CMO of a top-10 pharmaceutical company now works with Alacrita clients on a fractional basis, spending 16-24 hours per week embedded with companies navigating complex fibrotic disease portfolios.
Executive Transition
Maintain momentum during CMO searches. An interim CMO can keep trials on track, preserve institutional knowledge, and ensure continuity with regulators and partners.
Pre-IPO / Financing Readiness
Present a credible clinical story to investors. Our interim CMOs have presented to boards and participated in financing processes across company stages.
Phase Transition
Moving from Phase I to pivotal trials requires evolved capabilities. An interim CMO can provide oversight for critical go/no-go decisions and pivotal trial design.
Fractional / Virtual Biotech
For companies that need ongoing CMO-level guidance without a full-time hire, a fractional CMO provides consistent medical leadership: board participation, regulatory interactions, and strategic oversight, scaled to your stage and budget.
Recent Projects
Representative engagements illustrating how we support clinical development programs across stages and therapeutic areas.
Virtual stewardship of a targeted cancer therapy to IND submission
+Client: Early-stage biotech developing a targeted cancer therapy
Challenge: The company needed expertise to navigate an upcoming IND submission. Upon review of scientific data and ongoing trials, fundamental issues were identified that needed attention before the program could progress.
Solution: An Alacrita partner and medical oncologist with 25+ years of industry experience was integrated virtually into the team as interim CMO. Our consultant diagnosed the issues, mapped a new path forward to IND, and worked with the investigator-initiated trial investigator to expand the ongoing study. An Alacrita toxicologist was incorporated to manage collection of required safety data, and a senior regulatory consultant was added to prepare for the pre-IND meeting and IND submission itself.
Additionally, Alacrita performed a valuation of the clinical candidate using Monte Carlo simulation, producing projections for addressable market, pricing, development costs, and probabilities of success. The client leadership team was coached on how to position the data accurately to investors, and the valuation was used directly in the next funding round.
View full case studyTwo-year interim CMO for oncology company with three Phase I/II programs
+Client: Well-capitalized oncology company with approximately 80 employees, transitioning from research-focused biotech to clinical development organization
Challenge: The company was developing a portfolio of first-in-class small molecules targeting new cancer biology across genomically defined patient subsets. Three products were in Phase I clinical trials in hematologic malignancies and solid tumors. They needed CMO-level medical leadership.
Solution: Alacrita placed a board-certified oncologist with extensive drug development experience as interim CMO. He spent significant time on-site and embedded into the team with diverse responsibilities including: leading the oncology clinical team, helping recruit and retain additional medical talent, advising the CEO on strategic clinical decisions, and representing the company at investor, partnering, and investigator meetings.
View full case studyInterim CMO for fibrosis company across multiple indications
+Client: Well-capitalized, private biotech with first-in-class and best-in-class compounds targeting inflammatory and fibrotic pathways
Challenge: As lead compounds progressed toward development, the company was considering a broad spectrum of disorders as initial and follow-on targets: liver fibrosis, idiopathic pulmonary fibrosis, renal fibrosis, and inflammatory bowel disease. They needed a CMO with deep development experience across fibrotic diseases.
Solution: Alacrita's acting CMO, a board-certified gastroenterologist/hepatologist with 10+ years in biotech and large pharma including as CMO of a top-10 pharmaceutical company, committed 16-24 hours per week embedded in the company with significant time on-site. His responsibilities included advising on strategic clinical decisions, assessing disease targets across the fibrosis portfolio, supporting the biomarker discovery team, leading clinical development, designing clinical trials, supporting IND/IMPD submissions, and building out the development organization.
View full case studyClinical and medical support for leading immuno-oncology biotech
+Client: Leading immuno-oncology biotech with pipeline of novel, first-in-class clinical-stage assets
Challenge: The company needed medical support for multiple clinical and medical affairs activities across Europe and the United States.
Solution: Our team provided comprehensive support including: clinical strategy and execution of clinical development plans, drug safety and pharmacovigilance, fostering relationships with key opinion leaders, medical advisors and advisory boards, and assessing portfolio expansion opportunities from a clinical development and medical perspective.
View full case studyManaging preclinical programs into Phase I/II clinical trials
+Client: Leading cancer research charity
Challenge: The organization needed project management and drug development expertise to shepherd two preclinical programs into Phase I/II clinical trials.
Solution: Alacrita was responsible for overseeing the formal preclinical development program, IND submission, and execution of Phase I/II clinical trials for two targeted therapy compounds. Our duties included: identifying and negotiating CRO contracts, managing CRO relationships, ensuring regulatory compliance, liaising with ethics committees, monitoring GMP compliance, and providing regular progress reports.
View full case studyDevelopment support for first-in-class pediatric oncology drug
+Client: Listed US biotech with marketed products
Challenge: The company was developing a first-in-class immunotherapy for a pediatric oncology population and needed specialized expertise in pediatric trial design, regulatory considerations, and compliance with EU Paediatric Regulation and US BPCA/PREA requirements.
Solution: Alacrita's pediatric oncologist consultant provided ongoing support with Phase I/II design, protocol development, and medical oversight. The drug continues to be investigated in clinical trials.
View full case studyClinical Development Case Studies
Assessing a new inhalation device and assisting with partnering
Clinical and regulatory support for respiratory delivery specialist
Development plan for a bio-scaffold in spinal cord injury
Clinical protocol review in oncology
Frequently Asked Questions
How is Alacrita different from a staffing agency or expert network?
+Staffing agencies connect you with professionals who then work for you directly. Expert networks like GLG provide brief consultations, typically hour-long calls. Alacrita is different: your contract is with us, and we take responsibility for delivery throughout the engagement. We manage the work, review deliverables, and remain accountable whether it's a 3-week project or an 18-month interim CMO role. Our consultants work for Alacrita, not as independent contractors.
What types of companies does Alacrita work with?
+We work with biotech and pharmaceutical companies at all stages, from seed-stage virtual biotechs to established pharmaceutical companies, as well as life science investors and academic institutions. We're particularly well-suited for companies at critical inflection points: approaching IND submission, transitioning from Phase I to pivotal trials, preparing for financing, or navigating an unexpected leadership gap.
Can Alacrita support clinical programs in both the US and Europe?
+Yes. Our consultants have experience with FDA, EMA, MHRA, and other regulatory authorities. We have supported IND submissions in the US, MAA submissions in Europe, and global development programs spanning multiple regions. Our team includes former FDA and EMA reviewers with firsthand knowledge of how agencies evaluate submissions. We have offices in Cambridge, MA and London.
Do Alacrita consultants have deep therapeutic area expertise?
+Yes. Our 150+ clinical development consultants span 22 disease areas including oncology, rare diseases, CNS, immunology, fibrosis, and hematology. These are former CMOs, VP Clinicals, and Medical Directors who have led development programs in specific therapeutic areas, not generalists. When you engage us, we match consultants with direct experience in your indication and modality. For example, our oncology consultants include former pharma CMOs and medical directors who have led pivotal trials in both solid tumors and hematologic malignancies.
What does an interim CMO engagement with Alacrita look like?
+Our interim CMOs are physician executives who have held full-time CMO roles at pharma and biotech companies. Engagements vary based on need: some are full-time during executive transitions, others are fractional (16-24 hours per week) for virtual biotechs. Typical responsibilities include clinical trial oversight, board presentations, investor meetings, FDA/EMA interactions, and clinical team leadership. Engagements can range from months to multiple years. For example, one of our interim CMOs spent two years embedded with an oncology company overseeing three Phase I/II programs.
How quickly can Alacrita staff an engagement?
+For most project-based work, we can have consultants engaged within 2-3 weeks. For interim executive roles or highly specialized expertise, allow additional time for optimal matching. In urgent situations, such as unexpected departures before critical submissions, we have stepped in within days to maintain continuity.
Does Alacrita only do advisory work, or can consultants execute?
+Our consultants do hands-on work, not just advisory. They can write your protocols, prepare your FDA briefing documents, manage your CRO relationships, represent you in regulatory meetings, and oversee your clinical trials. The level of involvement depends on your needs. Some engagements are strategic assessments; others involve consultants serving as your clinical development function for extended periods.
Discuss Your Clinical Development Needs
Tell us about your program and we'll connect you with a relevant expert to discuss how we can help.