Interpretation
of clinical data and preparation of clinical study reports according to international (ICH) standards
Preparation
of Integrated Summaries of Efficacy (ISE) and Integrated Summaries of Safety (ISS) for regulatory submission
Clinical
Modules of Common Technical Documents (CTD) for regulatory submission
Systematic
data reviews
Risk Management Plans
Preparation
of abstracts and manuscripts for publication in peer-reviewed journals
Safety Reviews
Development of safety/pharmacovigilance plans (e.g. SAE Management Plan, Interim Safety Review
Plan), procedures, guidelines
Design and participation in interim reviews of safety data in ongoing trials
Support
for DSMB activities (including development of DSMB Charter and design and coordination of safety data reports for regular
review, liaising with the DSMB on data and/or safety issues, etc.)
Risk-benefit reviews and summaries
Preparation of safety summaries
and reports (developmental or periodic safety update reports, annual safety reports) for regulatory submission
Review
and preparation of custom reports for detection of unexpected adverse events (AEs) or changes in the profile, frequency or
intensity of AEs
Review of AE coding (to MedDRA), including development of study- or indication-specific coding guidelines
and of concomitant medication (WHODD/ATC) coding
Other Clinical Trial Support Services
General clinical research / scientific consultation
Literature searches and summaries
Development of training programs
Design and management of adjudication process for outcome events
