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 study design, regulatory submission or looking to find a partner for your program. As part of your Clinical Development team we are experienced and aim to support you across three critical aspects: data, documentation, and interactions.
Data
Study start up and database activities
Medical data review and coding
Review and Medical Monitoring of SAEs, AEs and AESIs (including treatment-associated toxicities)
Protocol deviation review and trend evaluation
Emergency database lock assistance
Biomarker review (e.g. genomic sequencing, tumor mutation burden, microsatellite stability)
Anti-tumor efficacy assessments, indication-specific, for solid tumors and hematologic malignancies (examples: based on Lugano classification, RECIST 1.1, RANO, iwCLL, NCCN guidelines, etc.)
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
Our oncology experience is evident in everything we do.
Clients Who Trust Us
