Whether you're a small pharmaceutical, start-up or emerging biotech; it’s important that your study runs smoothly and avoids delays as every study is pivotal to your business.
With 32% of regulatory submissions failing on technical criteria due to data conformance issues, often resulting in over a year of delay, ensuring your data is the highest quality is critical to achieving regulatory approval.
Whether you’re lacking in-house resource, expertise, or simply want to ensure data accuracy, our biometric focus is tailored to solve your needs and results in high quality data, rapid resourcing and no delays in getting your drug to market.
Support from study design through to submission
Plan
Bring biostatistics, data management and medical writing expertise into protocol development and study planning to assess endpoints, estimands, sample size, data requirements and downstream reporting needs.
Deliver
Access integrated support across clinical data management, biostatistics, statistical programming, medical writing and pharmacovigilance, delivered through one agreed governance model.
Submit
Prepare traceable datasets, analyses, outputs and documents that support regulatory submission and respond to review questions within the agreed biometrics and medical-writing scope.
CRO Services for Biotechs
Biostatistics
Understand your drug’s/device’s efficacy and safety profile with expert statistical analysis of your clinical research data.
Biostatistical Consultancy
Ensure efficient trial designs, analysis and study planning to streamline your clinical development efforts across all trial complexities to reduce costs and save time.
Statistical Programming
Turn un-interpretable validated clinical data into something meaningful with clinical trial reporting to make informed decisions and submission ready deliverables.
Clinical Data Management
Flexible and modern data collection, capture and management methods for your research data to ensure error free and timely database locks.
Medical Writing
Give your regulatory submission the best chance for approval with well written regulatory documents throughout all stages of the drug development process.
Pharmacovigilance
Quanticate offers a fully compliant and high-quality complete package of pharmacovigilance services.
ISS/ISE Submissions
Perform analysis and draw conclusions across multiple studies to accelerate submission and approval processes.
Real World Evidence
Harness insights that support health economics and outcomes research (HEOR) through our specialist team support with observational studies and post-approval safety research.
What challenges and pain points do biotech companies face?
It’s common for early and mid-stage biotech companies to have lean internal developmental infrastructure as they focus on a limited pipeline compared to larger drug developers. This brings speed and scientific focus to their operations, but it also means many capabilities needed for clinical development must be accessed externally, therefore making outsourcing a structural choice as much as a cost one. In addition, as biotech’s typically have a smaller pipeline than pharmaceutical companies, the success of the molecule is only more important to the success of the business.
To reach key milestones without overextending internal teams, biotech sponsors commonly use a mix of CRO and Functional Service Provision (FSP) models. FSP models can augment internal capability by embedding dedicated specialist roles or teams within the sponsor’s operating model, while CRO delivery models reduce internal burden by taking ownership of defined trial activities and study-level deliverables. Large pharmaceutical companies also outsource, doing so from a position of established infrastructure and mature processes, while biotechs often rely on more integrated external support until internal capabilities develop.
A key operational decision is whether to use multiple vendors or consolidate. Some sponsors choose best-of-breed suppliers, for example, separate providers for clinical operations and biometrics, or different specialists for data management, statistical programming, and biostatistics. This can improve performance, however, coordinating multiple providers increases governance effort and can introduce handoff risk, misalignment on data standards, and avoidable delays.
For many biotech companies, the most effective consolidation point is within biometrics. Clinical development programmes often depend on specialist vendors such as biometric CROs to handle clinical data and statistical analysis. Selecting one biometric CRO such as Quanticate to deliver data management, biostatistics, programming, and medical writing under a single governance model can centralise oversight, reduce complexity, and preserve flexibility. Biotech sponsors can then choose the most suitable approach for clinical operations separately, while keeping biometrics consistent, submission-focused, and accountable.
Frequently Asked Questions
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What is biotechnology in clinical research?
Biotechnology in clinical research is the use of biological systems and living organisms to develop, test, and improve new medical treatments to improve human health. In contrast to pharmaceuticals that focus on the development of chemical compounds, biotechnology uses molecular biology for new drugs and therapies, and typically comes in the form of personalised medicine, cell and gene therapy (CGT), vaccines, and biologics like monoclonal antibodies.
When and why do biotech companies work with CROs?
Biotech companies typically work with CROs when they need to progress clinical programmes quickly without building large internal teams. Rather than hiring permanent specialists for activities such as clinical data management, statistical analysis, and trial reporting, many biotechs outsource to CROs to access experienced teams, proven processes, and established infrastructure on a flexible basis. This approach helps control costs, reduce operational risk, and maintain focus on core scientific and strategic priorities, especially when timelines and funding milestones are critical.
Why choose a specialist biometric CRO rather than a full-service clinical CRO?
A full-service clinical CRO can simplify governance by managing a broad range of trial activities under a single contract, which is an attractive option for lean biotech teams. However, biometrics is the area most closely tied to data conformance, statistical integrity and regulatory acceptance, and it is also where many trials encounter avoidable issues.
A specialist biometric CRO brings deep expertise in data quality, statistical design, analysis, and reporting. For biotech companies running complex or data-intensive studies, this focused expertise reduces rework, supports clearer decision-making, and increases confidence in regulatory submissions. By working alongside a clinical CRO, a biometric CRO allows sponsors to retain the governance benefits of clinical delivery while ensuring biometrics receives the specialist attention it requires, without adding unnecessary operational overhead.
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