Standard & complex BE
Conventional, replicate and partial-replicate designs, including highly variable drugs and challenging formulations.
Start a conversation ↗Scientific expertise
Evidence designed for
real development challenges.
Scientific depth and connected delivery for programmes that demand more than routine execution.
Integrated thinking
Expertise connected around the evidence you need.
Questra brings clinical operations, bioanalysis, regulatory science, data and reporting together around each product’s development question.
Our teams design fit-for-purpose approaches for conventional and complex bioequivalence studies, early clinical development, specialised analytical programmes and products that require tailored evidence pathways.
By considering clinical feasibility, analytical performance, operational risk and regulatory expectations together, we help sponsors identify challenges earlier and build stronger, more coherent evidence packages.
Hybrid & FDC pathways
Tailored scientific and regulatory evidence for fixed-dose combinations, bridging strategies and hybrid applications.
Clinical pharmacology
PK/PD strategy, DDI evaluation, early-phase execution and specialised analytical planning.
Advanced bioanalysis
LC–MS/MS method development, validation and quantitative sample analysis for small molecules.
Data & biostatistics
Data management, pharmacokinetic calculation, statistical analysis and integrated interpretation.
Quality systems
ICH-GCP-aligned clinical operations, GLP expertise, quality assurance and risk-based oversight.
End-to-end delivery
A connected path from strategy to report.
Capabilities can be combined into an integrated programme or selected to strengthen a specific stage of development.
- 01Feasibility, scientific strategy and study design
- 02Protocol, ethics and regulatory documentation
- 03Site preparation, recruitment and clinical conduct
- 04Bioanalytical method development and sample analysis
- 05Data management, pharmacokinetics and biostatistics
- 06Integrated reporting and submission-ready outputs