With established pipelines and large portfolios, medium to large sized pharmaceutical and biotechnology companies have the challenge of executing clinical programmes, efficiently, consistently, and at scale, all within a market with increasingly higher costs of drug development and study complexities.
Quanticate provides specialist biometric support to maintain data quality, regulatory readiness, and operational momentum as programmes expand. Using either embedded expertise, full functional teams, or study-level delivery, we align to your established standards, governance structures, and preferred-provider frameworks to support your clinical trial.
CRO Services for Mid-Large Pharmaceutical and Biotech Companies
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 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 in line with the latest regulatory guidance.
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
Ensure data standardisation and regulatory compliance 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 mid-large pharmaceutical and biotech companies face?
Mid-sized and large pharmaceutical companies often manage broad portfolios with multiple studies running in parallel across regions and therapeutic areas. This scale increases the number of stakeholders involved in oversight and decision-making, which can slow delivery if information is not consistent and decisions are not supported by a clear, shared view of programme status.
as organisations frow, complexity also increases across systems and suppliers. Data, outputs, and documentation may be produced across different platforms, teams, and partner networks, making it harder to maintain a single version of truth and creating friction when programmes need rapid answers or cross-study visibility.
These sponsors also face heightened scrutiny and governance expectations. Inspection readiness, traceability, and robust documentation need to be maintained consistently across programmes, even when delivery is distributed across internal teams and external partners.
The result is a constant balancing act between speed, quality, and control at portfolio level. Sponsors need partners who can operate within established governance, deliver reliably under oversight, and support clear decision-making without adding operational burden.
These challenges make consistency, traceability and scalable biometric delivery critical at portfolio level, particularly when delivery is distributed across internal teams and multiple partners.
Frequently Asked Questions
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When do mid-sized and large pharmaceutical biotechnology companies work with CROs?
Mid-sized and large sponsors typically work with CROs when internal teams need additional capacity or specialist expertise across a portfolio, particularly as programmes become more complex and timelines tighten. Outsourcing is often used to maintain predictable delivery and consistent standards across studies, without expanding permanent headcount or disrupting established governance.
Why choose a specialist biometric CRO rather than a full-service clinical CRO?
A sull-service CRO can simplify oversight for operational delivery, but biometrics is often where portfolio consistency is won or lost. A specialist biometric CRO focuses on standardised data management, statistical programming, biostatistics and reporting, helping ensure traceable, inspection-ready outputs and cross-study comparability. Working alongside your chosen clinical delivery model, this approach strengthens control and consistency in the functions most critical to confident decision-making and regulatory-readiness.
How do you work within preferred-provider and sponsor governance models?
We align to sponsor standards, documentation practices and oversight requirements, and can deliver as embedded support, functional teams or study-level delivery. This enables consistent outputs and predictable performance while fitting into existing governance and vendor management structures.
