Biotech & Pharma
For biotech and pharma teams that need rigorous study methodology, biostatistics and regulatory documentation support.
Who this is for
Clinical, biometrics and regulatory affairs teams in biotech and pharma organisations preparing evidence packages, protocols, analyses and submission-oriented documentation — from emerging biotech programmes to large pharmaceutical writing surges.
Typical problems
- Submission documentation surge with limited writing capacity
- Analysis plans or outputs that are hard to interpret across functions
- Gaps between scientific objectives, endpoints and statistical methods
- Cross-functional narrative that does not hold under review
- Tight timelines for FDA- or EMA-oriented packages
Example scenarios
- Protocol lock — design options, estimands and endpoint coherence before operations scale
- Biometrics surge — SAP-aligned analysis support in R, Python, SAS, SPSS or Stata as the programme requires
- Regulatory writing — structured packages for FDA-oriented pathways (see anonymised selected work)
- Dual-market evidence — shared science with region-specific documentation vocabulary kept explicit
How we approach Biotech & Pharma programmes
We align methodology, data interpretation and regulatory writing early so packages stay coherent. Stages follow How we work:
- Discover — programme goals, evidence gaps, stakeholders and constraints
- Frame — scope of statistical, study-design and/or writing support; clear exclusions
- Build — analysis plans, protocol/methodology support, structured regulatory writing
- Harden — consistency checks, review-ready structure, handoff notes
- Hand over — artefacts and next steps toward agencies; the client remains sponsor and party of record
What we typically deliver
- Biostatistics and analysis planning/execution support as agreed
- Clinical study design and protocol structuring support
- Regulatory writing for submission and interaction materials
- Coordination across science and RA so the technical story stays consistent
Relevant expertise
Biostatistics · Clinical study design · Regulatory support · Selected work
For role boundaries (regulator, notified body, certification, outcomes), see Trust.
Ready to discuss a programme?
Tell us about your organisation and the type of support you need.