If you're a biotech planning a clinical trial, about to sign with a CRO, or already running a study that needs closer management, we can help. We work on your side of the CRO relationship. We can help you choose the right CRO and negotiate the right contract, get the most out of it once the study starts, cut out unnecessary spending, and most importantly be your agent on the ground to keep the study on time and budget.
Many biotechs reach this point without a full clinical operations team, or with one that's already stretched. Our consultants have run trials at sponsors and at CROs. They bring hard-earned experience of the problems trials commonly run into, and know how to spot them early. They work as part of your team, so you get the experience you need without building a department to get it.
As a study moves, it can need specialist input: a physician on a medical question, or a statistician on the analysis plan. We can bring that into the same engagement, under the same management and accountability, so you aren't left finding and coordinating another contractor. We're not a CRO and we don't conduct studies; we help you hold the one you hire to what it agreed.
For a clinical-stage oncology biotech, an Alacrita clinical operations lead has managed the sponsor's side of a Phase 1 program since start-up in 2023. The engagement has since taken on a second trial and continued under a new chief medical officer. More engagements below.
Planning a trial, or running one? Talk to us.
Where the Value Is
If this is your first clinical trial, the CRO contract is likely among the largest you've signed. The contract sets what the CRO delivers. How the relationship is managed shapes how smoothly the study runs, what it ends up costing, and whether problems are caught while they can still be fixed.
Starting with the right CRO and contract
The CRO and contract you start with set how much of the study you can still steer later. We can run the selection and negotiate the contract with you; see CDMO and CRO selection and management.
Holding the CRO to the contract
We can manage the relationship on your behalf, with:
- Regular governance reviews with the CRO
- Invoices checked against plan and budget
- Change orders challenged or agreed, with our recommendation
- Performance issues raised and followed through
- Decisions brought to you when they're needed
Catching problems early
We know where studies tend to go wrong, and keep watch on:
- Enrollment, so a shortfall is caught in month three, not month nine
- Deviations, so a pattern is fixed before it becomes an inspection finding
- Data quality and safety questions, raised with you as they come up
- Costs, so a change order is questioned before it's invoiced
What We Manage for You
How we keep you informed depends on your study and your team: a weekly call, a written update, a governance meeting with the CRO, or a conversation when something needs a decision. Whatever the format, these are the areas we manage and keep you informed on.
Enrollment
Progress by site against plan, and what to do when it falls behind.
Site start-up
Approvals, contracts, and site activation, and what is holding up the next site.
Data quality and conduct
Deviations, monitoring findings, and readiness for database lock.
CRO performance and cost
Milestones and budget against the contract, with change orders and invoices reviewed.
Safety and medical questions
Reviewed by an Alacrita physician where medical oversight is part of the engagement.
Risks and decisions
Each with the options, our recommendation, and when a decision is needed.
Our lead can represent you with the CRO or advise your own team. The structure is yours to choose.
Areas of Work
You can engage us for any of these on its own or in combination, at whatever point your study has reached. The table shows where each usually falls. For the wider clinical development program, see clinical development.
| Service | Before the first patient | While the study runs | After the last patient |
|---|---|---|---|
| Study planning and CRO selectionBefore the first patient | |||
| Study start-upBefore the first patient | |||
| Trial managementWhile the study runs, through database lock | |||
| Medical oversight and medical monitoringBefore the first patient through the end of the study | |||
| Interim clinical leadershipAt any stage | At any stage | ||
Study planning and CRO selection
Choosing the CRO is one of the first big decisions on a trial, and bigger is not always better. A large CRO can be the right choice for a global study, but a smaller sponsor may not get its most experienced team or its full attention. What matters is the team you'll actually get: who is proposed, how much of their time, how much senior attention, and how escalation works, alongside technical fit and price. We can help you set the study plan and budget the CRO bids against, choose a CRO that fits the study, and negotiate a contract that gives you the right people and services and pays only for what you need. How we run selection is described under CDMO and CRO selection and management.
This can include
- The study timeline and budget assumptions
- The CRO scope of work
- Shortlist, bids, and selection
- Contract negotiation
Who you'd work with: Alacrita associate consultants who have set study plans and budgets and taken CROs through selection and contracting from the sponsor side, from first-in-human through Phase 3. They include a head of clinical operations who selected the CROs for five trials at venture-backed biotechs, one of them a pivotal Phase 3.
Study start-up
Before the first patient is dosed, the protocol and investigator's brochure, ethics approvals, site contracts and budgets, and the CRO's own readiness have to come together. We can manage them as one plan, so whatever is holding up a site is found and cleared early.
This can include
- Start-up plan and tracking
- IRB and ethics submissions, tracked and followed through
- Site contract and budget negotiation, directly or through the CRO
- CRO and vendor readiness reviews
- Oversight of site initiation
Who you'd work with: consultants in clinical operations and clinical quality who have taken Phase 1 through Phase 3 studies through start-up and site activation at sponsors and at CROs.
Trial management
Once patients are enrolling, we can manage the study on your behalf: holding the CRO to the contract, tracking enrollment, deviations, data quality, and costs against plan, and bringing you decisions as they arise.
This can include
- Governance meetings with the CRO
- Enrollment and deviation tracking, with recommendations
- Site relationships and recruitment reviews
- Clinical quality and GCP issues raised and followed through
- Oversight of specialist vendors such as central and imaging labs
- Invoice and change-order review against the contract
Who you'd work with: consultants who have run clinical operations and clinical quality from the sponsor side, alongside former CRO project directors who know what sits behind the reports you receive. They include a former senior director of global clinical operations at an international CRO and a former FDA investigator who conducted GCP inspections.
Medical oversight and medical monitoring
Trials raise medical questions: whether a patient is eligible, whether a dose should continue, what an adverse event means for the study. We can provide a physician on your side to answer them, review trial and safety data, and prepare for DSMB meetings, either as the study's medical monitor or overseeing the CRO's, depending on how the engagement is set up.
This can include
- Medical monitoring
- Data and patient profile review
- Eligibility and dosing questions from sites
- Safety event review
- DSMB preparation
- Medical input to study decisions
Who you'd work with: consultants who have served as chief medical officers and lead medical monitors, including an oncologist who was lead medical monitor on a Phase 3 registration study in acute myeloid leukemia.
Interim clinical leadership
If you're between chief medical officers, or need one before you can justify the hire, one of our physicians or clinical development leaders can step in as interim chief medical officer, medical director, or clinical lead. They can run the function through a program, a filing, or the search for a permanent hire, then hand over or stay on alongside the new leader. On when a fractional role fits, see our article on fractional CMOs.
This can include
- Leading the clinical team
- Representing you with investors, partners, investigators, and regulators
- Helping evaluate candidates for the permanent role
Who you'd work with: consultants who have held chief medical officer and medical director roles at biotechs and pharma companies, from first-in-human through registration.
Additional Capabilities as the Study Needs Them
At some point many trials need more than operations and medical oversight: a protocol reworked, the statistics behind the analysis, a clinical study report, or a safety function set up. We can add these to the same engagement, scoped to what the study needs.
- Study design and protocols. From physicians and clinical development leads who have written Phase 1 through Phase 3 protocols.
- Endpoints and inclusion criteria
- Review of the protocol before it is locked
- Biostatistics. From statisticians including a chartered statistician who has co-authored published Phase 3 oncology trials. We can keep the same statistical team from the plan through to the results.
- Sample size and power
- The statistical analysis plan
- Randomization
- DSMB statistical support
- The analysis when the data comes in
- Trial documents and reporting. From physicians and regulatory medical writers who have taken these documents through agency review.
- Investigator's brochures
- DSMB charters
- Clinical study reports through to submission
- Pharmacovigilance and drug safety. Led by drug safety physicians who have built safety functions at small biotechs, headed global safety, and served as EU QPPV.
- Setting up the pharmacovigilance system
- Selecting and managing the safety database vendor that handles case processing and expedited reporting
- The safety management plan
- DSURs and other aggregate reports
- Signal evaluation
- Safety data exchange agreements with partners
Issues We Help Prevent
Trial problems are cheaper to fix the earlier they're found. These are some of the common ones we watch for.
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A protocol that can't answer the question
We review endpoints, inclusion criteria, and sample size with you before the protocol is locked, so the study can support the decision that comes after it.
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A study plan the CRO didn't bid against
We set the timeline and enrollment assumptions with you before the CRO scope is written, so the contract reflects the study you mean to run.
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Enrollment falling behind unnoticed
We track enrollment against plan from the first site and recommend changes to sites, criteria, or timeline as soon as it slips.
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A study slipping down the CRO's priority list
Regular governance and a clear escalation route on your side mean slippage is raised on a schedule, not when someone happens to notice.
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Scope creep that arrives as a change order
We flag operational changes as they happen, so a change order reaches you already explained and with our recommendation.
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You and the CRO working to different assumptions
Scope, responsibilities, and reporting are agreed at the start and revisited at each review, so a difference surfaces as a discussion, not a dispute.
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A medical or safety question with no one on your side to answer it
Where medical oversight is part of the engagement, an Alacrita physician answers it, working with the CRO's medical monitor and safety team.
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A gap in clinical leadership at the wrong moment
An interim chief medical officer or clinical lead can take on the function at short notice, so decisions and filings don't have to wait for a hire.
If one of these sounds familiar, get in touch.
When to Engage Alacrita
Where clients usually start. The first four follow the life of a study; the last two can happen at any point. The earlier we're involved, the more of the CRO contract is still open to shape.
Before the protocol is final
Design, endpoints, and inclusion criteria can still change, and your study plan and budget are set before the CRO bids against them.
While choosing a CRO
The CRO's scope and your contract are negotiated with the design and budget in hand.
Before the first site opens
Governance with the CRO is in place before the first patient, so reporting and escalation routes are ready when the study starts.
With a study already running
We start with a review of the protocol, the CRO's scope of work, and where the study stands, then set up governance for the rest of the study.
Alongside your clinical team
We add to your team rather than replace it, with responsibilities agreed at the start.
When clinical leadership changes
We can cover the transition and help you evaluate candidates for the permanent role.
Selected Engagements
Examples of our work managing CROs and trials, providing medical oversight, and leading clinical teams, with study design and biostatistics where a program needed them, for companies from university pre-spinouts to European pharma.
Clinical-stage biotech · Oncology
A clinical-stage oncology biotech taking its lead candidate through a Phase 1 dose-escalation study needed senior clinical operations leadership with biotech experience, without immediately adding a permanent executive.
Alacrita provided an SVP-level clinical operations lead who has worked inside the company's clinical team since study start-up, managing the CRO and study vendors, tracking enrollment and site performance, and reporting to the company's executive team. The same lead, in place since study start-up in 2023, has since taken on a second trial for the company and now reports to the chief medical officer appointed during the engagement.
Cancer research charity · Small molecules · Oncology
A cancer research charity needed drug development and project management expertise to take two preclinical targeted therapy programs into Phase 1/2 trials.
Alacrita oversaw the formal preclinical program, IND submission, and the CROs' execution of the Phase 1/2 trial. The work included identifying CROs and negotiating contracts with them, managing those relationships, resolving issues as they arose, monitoring regulatory compliance, liaising with ethics committees, monitoring GMP compliance, and reporting progress to the client.
Clinical-stage biotech · Small molecules
A biotech preparing its first efficacy trial, to be run at sites overseas, engaged Alacrita in stages as the program moved: first for chief medical officer level advice on clinical strategy, then for the biostatistics behind the trial design and the statistical analysis plan, and once enrollment began, for a medical monitor based at the study sites.
The medical monitor identified a problem in how study samples were being collected that would have limited what the data could show, and it was corrected during the study. The engagement is ongoing, with clinical strategy, statistics, and medical monitoring on one program.
European pharmaceutical company · Small molecules · Oncology
A major European pharmaceutical company needed interim medical support for its clinical development activities over a three-year period.
Acting as clinical directors, Alacrita physicians based in Europe provided development strategy advice in first-line pancreatic cancer, small cell lung cancer, and other indications; protocol review and development; data review, including data coding and patient profile review; trial oversight; and oversight of clinical study report writing and manuscript preparation.
Biotech · Oligonucleotide therapy · Orphan disease
A company developing a new class of oligonucleotide therapy for a rare lysosomal storage disorder could not define its recommended Phase 2 dose because the biomarkers fluctuated, and needed a dosing strategy and a set of assays to address it.
Over two years, an Alacrita clinical development specialist with clinical pharmacology expertise supported the company through trial design and regulatory submissions, including the approach to defining the recommended Phase 2 dose, working with an Alacrita medical writer and a biomarker specialist experienced in qualifying biomarkers as clinical endpoints. The trial was approved and initiated during the engagement.
Oncology biotech · Small molecules · Hematologic and solid tumors
An oncology company of around 80 people, with three first-in-class small molecules in Phase 1 or Phase 1/2 trials, needed a chief medical officer as it moved from a research organization to a clinical development one.
For two years, a board-certified oncologist from Alacrita served as interim chief medical officer, on site each week. He led the oncology clinical team, helped recruit and retain additional medical talent, advised the CEO on strategic clinical decisions, and represented the company at investor, partnering, and investigator meetings.
Private immuno-oncology biotech · Small molecules and antibodies · Oncology
A privately held immuno-oncology company lost its chief medical officer suddenly and needed interim support while recruiting a replacement.
Alacrita provided chief medical officer support, contributing to the design of a first-in-human dose-escalation trial, as monotherapy and in combination with an anti-PD-1 antibody, and to the clinical development plan for the company's next agent. The Alacrita physician joined IND preparation meetings and sessions with the lead investigator, sat with the executive team in due diligence meetings with venture investors ahead of a Series B financing, and helped evaluate and interview candidates for the permanent CMO role.
Private biotech · Inflammatory and fibrotic disease
A private biotech with first-in-class compounds targeting inflammatory and fibrotic pathways was weighing liver fibrosis, idiopathic pulmonary fibrosis, renal fibrosis, and inflammatory bowel disease as initial and follow-on indications, and needed a chief medical officer with development experience in fibrotic disease to make that choice and plan the first studies.
Alacrita's acting CMO, a board-certified gastroenterologist and hepatologist who had been chief medical officer of a top-10 pharmaceutical company, worked embedded in the company with significant time on site. He assessed the disease targets across the fibrosis portfolio, led clinical development and trial design, supported the biomarker discovery team and the IND and IMPD submissions, advised on strategic clinical decisions, and helped build the development organization.
European pharmaceutical company · Small molecules · Endocrine and metabolic
Five months before a planned MAA submission for a neuroendocrine indication, the company's medical director and other key team members left and could not be replaced internally.
An Alacrita physician acted as medical director for the registration. Over the five months the team finalized the study reports, wrote the clinical overview and the SmPC, prepared an orphan drug designation application, and answered the rapporteurs' questions, including new statistical analyses of the clinical data. The Alacrita physician represented the company in agency meetings through to approval, then prepared submissions for other non-US territories before handing the dossier to the client's commercial team.
University pre-spinout · Small molecules · Ophthalmology
A university pre-spinout venture developing a repurposed molecule in a new delivery system for diseases of the back of the eye needed to strengthen its translational and clinical development capability to support planning and fundraising.
Alacrita provided a former chief medical officer with ophthalmology experience who joined the team remotely, giving the venture senior clinical input into its planning and fundraising without a full-time hire.
Want to talk about your study? Get in touch.
Selecting or managing the CDMOs and CROs behind a program? See CDMO and CRO selection and management.
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Related Reading
- Bridging the gap: how fractional CMOs propel biotech success
Why early-stage biotechs reach for senior medical leadership before they can justify a full-time hire, and what a fractional chief medical officer takes on.
- The biotech company is not the product
On adding fixed costs before the asset has earned them, and accessing stage-specific capability without building permanent infrastructure.
- The perils of misaligned incentives: why drugs fail late in development
How rushed milestones and optimistic interim reporting carry weak candidates forward, and why management should demand a harder look at the data.
The CRO's project team manages the CRO's delivery of its contract. Alacrita works for you: managing that delivery against your plan, budget, and priorities, and bringing you what needs a decision.
No. The CRO conducts the study. Alacrita manages your side of it: start-up, delivery, deviations, medical oversight, costs, and the decisions you need to make, and can bring in design and statistical specialists where the trial calls for them.
Yes. Alacrita often adds capacity, specialist input, or interim cover to an existing team, for example protocol review, medical monitoring, pharmacovigilance, or a senior clinical lead for part of a program.
Yes. Alacrita starts with a review of the protocol, the CRO's scope of work, and where the study stands, then sets up regular governance and communication for the rest of the study.
Yes, as a specialist capability alongside the trial team: statistical input to the protocol and sample size, the analysis plan, randomization, DSMB support, and the analysis when the data comes in. Alacrita can keep the same statistical team from plan to results, so there is no hand-off between teams at database lock.
Yes. Interim leadership is a core part of the service, and each engagement defines the responsibilities Alacrita takes on. Alacrita's associate consultants include former chief medical officers and medical directors across oncology, rare disease, fibrosis, antivirals, and immuno-oncology, and its clinical operations leads have run studies at biotechs and CROs. Engagements have included interim chief medical officers at biotechs, an interim medical director through an EU marketing authorization filing, and an embedded clinical operations lead for a Phase 1 oncology program. They run from a few months to two years or more, and can support a hiring transition or continue alongside a permanent hire.
It depends on what the study needs. Alacrita's proposal sets out the scope and work products, for example a start-up plan, defined trial management or medical oversight responsibilities, interim leadership, and, where specialists are engaged, a protocol, a statistical analysis plan, a safety management plan, or a clinical study report. A protocol or an analysis plan is a bounded piece of work; trial management continues for as long as you want it; interim leadership runs until the hire is made or you decide otherwise. Scope is revisited as the study moves.
That's your choice. Alacrita's lead can represent you with the CRO, with authority agreed in advance, or work alongside your own team and advise. The structure is set for each engagement and can change as your team grows.
Yes. Alacrita physicians and clinical operations leads have designed, managed, and monitored studies in the United States and Europe, including a medical monitor based at sites overseas, and the firm has offices in Cambridge, MA and London.
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