For Biotech
Our deep expertise in clinical development means we are ready to provide extensive support for your critical clinical trials, whether you are aiming for regulatory submission or looking to find a pharma partner for your program. We aim to support you across three main aspects of clinical science: data, documentation, and interactions.
Data
Study start up and database activities
Medical data review and coding
Anti-tumor efficacy assessments
(based on Lugano classification, RECIST 1.1, RANO, iwCLL)
Protocol deviation review and trend evaluation
Emergency database lock assistance
Biomarker review (e.g. genomic sequencing, tumor mutation burden, microsatellite stability)
Immune-mediated AE review and classification
Documentation
Clinical trial design and program planning
Trial documentation authoring (e.g. Investigator Brochure, Clinical Study Protocol, Clinical Study Report)
Patient material (e.g. Informed Consent Forms, Lay Clinical Trial Summary)
Investigational New Drug Applications and Biologics License Applications
Annual health authority reports
Medical and scientific input into filing submission documents
Scientific publications
Interactions
CRO selection and oversight
Site investigator meetings
Health authority interactions (e.g. FDA, EMA, NMPA, MHRA, PMDA, Health Canada)
Data monitoring committee meeting support
Investigator safety calls
Stakeholder communications
Data quality meetings
Due dilligence
