Protocol Writing & Study Design
Study rationale, protocol structure, endpoints, feasibility-informed design and scientific documentation.
Services
Tailored support from scientific planning to study close-out — with specialist services available as required.
Services / Scientific development
From scientific questions to workable protocols
Medical and scientific insight supports decisions before the first site is activated.
Medical Writing & Research Support
Clinical and scientific writing, observational and investigator-initiated research support, and translation/adaptation.
Scope is defined by project requirements, medical review and agreed deliverables.
Services / Biometrics
Biostatistics & Data Management
Data should be managed with the same care as the participants and scientific decisions behind it.
Biostatistics
Statistical planning, study analysis strategy, data interpretation and statistical reporting support.
Clinical Data Management
Data management planning, data review, cleaning, query workflows and database-related deliverables, as agreed.
Services / Trial operations
Clinical operations built for real sites
Practical, local execution across study set-up, conduct and close-out.
Clinical Monitoring
Risk-aware site oversight, issue identification and communication with investigator teams.
Project Management
Defined responsibilities, proactive coordination and practical issue resolution.
Feasibility & Site Selection
Investigator insight, realistic patient-pool assessment and site readiness.
Study Start‑up
Site activation planning, essential documentation and milestone coordination.
Regulatory Affairs
Local regulatory pathways for clinical trials, including ethics committee and competent-authority applications, and preparation of applicable submissions.
Contracts & Budgets
Transparent negotiations, local budgeting context and ongoing financial coordination.
Product licensing, lifecycle and marketing authorisation holder (MAH) work sits with Bpharma Regulatory Affairs.
Services / Specialist solutions
Specialist capabilities when the study needs more
Connected expertise rather than a one-size-fits-all package.
Radiology & Nuclear Medicine
Protocol-aligned specialist reading, reporting and imaging coordination.
Equipment & Calibration
Medical equipment leasing, calibration and fit-for-purpose support.
Genetics & Laboratory Services
Study-specific testing and laboratory service coordination.
Translation & Local Adaptation
Medical translation and local regulatory document adaptation.
Service availability and delivery arrangements are determined by country, protocol and partner qualifications.
Innovation / Built around needs
Innovation shaped by everyday trial challenges
We develop technology with practical research workflows in mind.
Imaging workflows
Tools under development to support more consistent specialist review and reporting.
Budget planning
Digital approaches aimed at clearer project costing and budget management.
Operational intelligence
Practical systems and tools to improve visibility, coordination and decision-making.
Innovation is a direction of development, not a claim that every software solution is commercially released.