If you're a biotech getting ready for IND-enabling work, choosing a CDMO or CRO, or managing vendors already under contract, we can help. Once you enter the clinic, your CDMO and CRO contracts are often among your largest commitments. We work on your side of them: specifying what each vendor must deliver, negotiating the contracts you sign, and putting a recommendation in front of you before major spending decisions.
The contract sets what each vendor delivers. How the relationships are managed through the work shapes how smoothly it runs, what it ends up costing, and whether problems are caught while they can still be fixed. You may reach this point before you have a Head of CMC or VP Clinical Operations, or with the roles filled but not the capacity. Our consultants have done this work inside biotechs, CDMOs, and CROs, and they work as part of your team.
Engaged early, we can specify each batch and study against what the IND needs from it, set the contract terms you'll need later, and keep manufacturing, toxicology, and clinical work on one schedule, with the work that can run in parallel identified up front. We're not a CDMO or a CRO; we help you hold the ones you hire to what they agreed.
For a publicly traded cell and gene therapy company with a small internal team, an Alacrita consultant managed the contract manufacturing relationships and IND-enabling studies from inside the R&D team. More engagements below.
Getting ready to choose a CDMO or CRO? Talk to us.
For managing the clinical trial itself, see clinical operations and trial management.
Areas of Work
The right CDMO or CRO depends on the stage of the program, the disease area, and the technology, and how you work with the vendor matters as much as which one you choose. You can engage us for any of these on its own or in combination. The table shows where each usually falls in a program. For the science and study strategy behind IND-enabling work, see preclinical development.
| Service | Before the IND | Filing the IND and opening sites | While the study runs |
|---|---|---|---|
| IND gap assessmentBefore the IND | |||
| CDMO selection and managementBefore the IND through the study | |||
| Toxicology CRO selection and managementBefore the IND | |||
| Clinical CRO selection and contractingBefore the IND, filing the IND and opening sites | |||
| Clinical CRO relationship managementFiling the IND and opening sites, while the study runs | |||
| Integrated clinical, CMC, and regulatory planningBefore the IND through the study | |||
| Interim CMC leadershipAt any stage | At any stage | ||
IND gap assessment
If work has already been done, the first question is what it supports. We can assess the existing data, materials, and vendor work against IND requirements and set out what needs to be redone, bridged, or explained before more money is committed.
This can include
- A written assessment against IND requirements
- The decisions the findings raise, with options
- A plan with cost and timing ranges
Who you'd work with: Alacrita associate consultants in CMC, regulatory, and nonclinical development who have assembled IND packages and assessed programs for investors and partners.
CDMO selection and management
We can shortlist manufacturing partners that fit the molecule and dosage form, negotiate the contract, and manage the CDMO from IND-enabling batches through clinical supply release. Before you commit, we can model a CDMO program's likely cost and timeline from the parameters that drive CDMO pricing, and if a CDMO is winding down, we can coordinate the transfer out.
This can include
- A shortlist screened on containment, chemistry, and capacity
- Bids on a common technical package
- Contract terms covering records, retained samples, methods, and transfer support
- Supplier audits
- Batch record and deviation review
- Tracking batch release against the program plan
Who you'd work with: consultants who have commissioned CDMOs from the sponsor side, led technology transfers into and out of them, run GMP supplier audits, and headed quality at manufacturers, alongside people who have run the business inside contract manufacturers and know how their proposals are built.
Toxicology CRO selection and management
IND-enabling studies need to answer what the IND and the clinical plan ask of them. We can help design them around those questions, choose a CRO that suits the study type, and coordinate test material and timing with manufacturing.
This can include
- Study design input
- CRO selection
- In-life monitoring
- Pathology peer review coordination
- Final report review
Who you'd work with: consultants who have directed GLP studies and planned IND-enabling programs.
Clinical CRO selection and contracting
Bigger is not always better. A large global CRO may be the right choice for a multinational study, but a small biotech there is one client among many, and the A teams tend to go to the largest sponsors. 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, weighed alongside technical fit and price. We can help you choose a CRO on that basis, write down the budget assumptions it bids against, and negotiate contract terms that keep scope changes visible.
This can include
- Scope of work and RFP
- Bids compared on common assumptions
- Bid defense meetings, attended or led as you prefer
- Contract and change-order terms
Who you'd work with: consultants who have commissioned CROs from the sponsor side, from first-in-human through Phase 3, and people who have run the business inside CROs and know how bids are built, how teams are staffed, and where a proposal's staffing can be challenged.
Clinical CRO relationship management
Once the contract is signed, we can manage it through the study: scope, change orders, invoices, and performance reviewed against what was agreed, with decisions brought to you when a change needs one. Managing the study itself, from start-up through enrollment and data quality, is covered under clinical operations and trial management; the two are often scoped together.
This can include
- Governance meetings with the CRO
- Scope and change-order review
- Invoice review against the contract
- Performance reviews
Who you'd work with: consultants who have run CRO governance, change-order and invoice review, and study budgets from the sponsor side.
Integrated clinical, CMC, and regulatory planning
Manufacturing, toxicology, regulatory interactions, and site activation depend on each other. We can schedule them as one plan, with the dependencies made explicit and the spending decisions that depend on FDA feedback identified in advance.
This can include
- An integrated program plan
- Pre-IND or EMA scientific advice meeting preparation
- A recommendation at the major spending decisions
- Board and investor updates
Who you'd work with: consultants in regulatory affairs who have prepared INDs, pre-IND packages, and EU clinical trial applications, including former FDA staff, working with the CMC and clinical leads.
Interim CMC leadership
If you need a Head of CMC before you can hire one, one of our senior CMC leaders can run the function and its vendors while you recruit, then hand over when the permanent hire starts.
This can include
- Day-to-day management of CMC and its vendors
- Representing you with the board, FDA, and investors
- Interviewing and assessing candidates for the permanent role
Who you'd work with: consultants who have been Heads of CMC, VPs of Manufacturing, and technical operations leaders at biotechs.
Issues We Help Prevent
Vendor choices, study specifications, and contract terms shape the options you have later. These are some of the common issues we watch for.
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Limited access to records and transfer materials
The contract is where these terms are settled. We negotiate for access to your own batch records, retained samples, and analytical methods, and for support with a later transfer to another site.
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Studies and batches that don't support the IND
We help set study designs, batch sizes, and specifications against the IND and the clinical plan, so avoidable repeat work is caught before the money is spent.
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A process the CDMO can't run without changes
We raise route and process questions before bids go out, so process changes are planned and priced in the CDMO's proposal rather than discovered mid-campaign.
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Shortlists that don't fit the molecule or the study
We build shortlists from what the molecule and the study require, before prices are compared.
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Bids that can't be compared
Differences in scope show up before the contract is signed, not in the first change order.
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Major spending ahead of FDA feedback
The program plan marks which studies and manufacturing commitments depend on FDA feedback, so you can decide those with the feedback in hand.
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Clinical start-up waiting for the IND
We schedule CRO selection, contracting, and site start-up alongside IND preparation and review rather than after it, as the charts below show.
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Scope changes and cost overruns that surface late
We review vendor progress, invoices, and change orders against the agreed scope and budget as the work goes.
If one of these sounds familiar, get in touch.
How Sequencing Changes the Timeline
The same activities, sequenced two ways. When clinical vendor work starts during IND preparation rather than after the IND clears, much of clinical start-up can overlap with FDA review. Illustrative, not to scale.
- Regulatory
- CMC and toxicology
- Clinical vendor work
Sequential: clinical vendor work begins after the IND clears
Parallel: clinical vendor work runs alongside IND preparation
When to Engage Alacrita
Where clients usually start, earliest first. The earlier we're involved, the more of the vendor work and contract terms are still open to shape.
Before IND-enabling work begins
We can set up CDMO and toxicology CRO selection, contract terms, and study design so the batches, studies, and documents you pay for support the IND.
With work done, before the IND
An IND gap assessment can establish what the existing work supports and shape the development plan.
With vendors already in place
We start from the contracts and work as they stand and take on their management from there. The FAQ below explains how that begins.
When a vendor is leaving
We can coordinate the transfer out; see CDMO selection and management.
Selected Engagements
Examples of our work choosing, auditing, and managing CDMOs and CROs on the sponsor's side.
Private biotech · AAV gene therapy · CNS
A biotech developing in vivo gene therapies had two lead programs in IND-enabling studies and needed CMC and regulatory experts with gene therapy and CDMO experience, including oversight of its manufacturing partners.
Alacrita provided a CMC and regulatory team to oversee the manufacturing partners. The team audited CDMO sites, met the CDMO routinely, and reviewed CMC reports, batch records, the CMC plan, and process development. It also provided QA/QC oversight and prepared the IND, the pre-IND meeting, and the EMA engagement and submission.
Public biotech · Cell and gene therapy · Infectious disease and oncology
A publicly traded biotech with a small internal team developing cell and gene therapies needed regulatory, CMC, and pharmacology and toxicology support for its lead program.
An Alacrita consultant with prior experience as a senior regulatory specialist at FDA worked inside the client's R&D team and with its external contract organizations. The work covered management of the contract manufacturing relationships, process and analytical method development, IND-enabling studies, and regulatory input into the first-in-human trial design.
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. Alacrita identified the CROs and negotiated their contracts, then managed those relationships through the trial. The team also liaised with ethics committees, monitored GMP compliance, and reported progress to the client.
Virtual biotech · AAV gene therapy · Ophthalmology
A virtual company with two AAV gene therapy programs needed expert review of studies run by CROs and academic collaborators, and a plan for the CMC and regulatory work required to reach IND.
Alacrita provided ongoing data review and preclinical recommendations, coordinated studies with CROs and academic collaborators, and built CMC and regulatory roadmaps setting out what each program needed, and in what sequence, to move through preclinical development into the clinic.
Public mid-cap biotech · Cell therapy · Oncology
A publicly traded mid-cap biotech negotiating a term sheet for a cell therapy asset had no commercial experience with the modality and needed to understand the CMC costs and timelines it would be taking on.
Alacrita set out the parameters and assumptions that drive a CDMO's pricing for technology transfer, process development, engineering runs, and GMP batches of a cell therapy, across six domains and more than 40 individual items, then built a time and cost model with likely ranges. The client used the model in its negotiations.
Want to talk about your program? Get in touch.
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As early as possible, ideally before IND-enabling CMC and toxicology work begins, when vendor selection, contract terms, and study design are still open. Companies also engage Alacrita with work already done or with vendors already in place.
It depends on the decisions coming up. Alacrita's proposal sets out the scope and work products, for example a gap assessment and development plan, a vendor shortlist and bid comparison, negotiated contract terms, or vendor management through a defined milestone, and how the work is revisited as FDA feedback comes in. An IND gap assessment is a bounded piece of work with a defined deliverable, vendor selection runs to a signed contract, and vendor management continues for as long as you want it. There is no fixed package.
You do. Alacrita negotiates those contracts on your behalf but does not sign them or take on the financial liability. You contract directly with your vendors and keep final authority over spending and technical decisions. Alacrita works on your side of those contracts: scoping, selection, negotiation of terms, change orders, and management of vendor performance.
Earlier than many teams plan for. Selection, contracting, site agreements, and ethics submissions can take months, and if selection waits for the IND, those steps are still outstanding when it clears. Starting CRO selection while the IND is being prepared lets clinical start-up run alongside manufacturing and FDA review.
Yours. Alacrita is not a CRO or a CDMO and does not run studies or manufacture product. In vendor selection, Alacrita works for you: the program's requirements determine the shortlist, and relevant experience with vendors informs the assessment.
Yes. Alacrita starts with a review of the contracts, scope of work, and current progress against the protocol or manufacturing plan, then sets up regular governance and communication.
Yes, if you want it. Alacrita's clinical operations and trial management service covers study planning and CRO selection, start-up, trial management, medical oversight, and interim clinical leadership, with specialists in study design, biostatistics, and pharmacovigilance where a trial needs them. It is often scoped in the same engagement as CRO relationship management.
Yes. Alacrita has offices in Cambridge, MA and London, has overseen vendors and clinical activities in the United States and Europe, and its regulatory leads have prepared EU clinical trial applications and INDs and supported EMA interactions.
Discuss Your Program
A few lines about where your program stands is enough to start the conversation.