Company’s Profile in Clinical trials
SciencePharma provides a full support on clinical project management, monitoring, data management, and statistical analysis for clinical trials. Dedicated to the quality service, SciencePharma helps the clients to reduce time-to-market costs and risks while maintaining strict compliance with all regulations and by using state-of-art operating procedures.
Clinical Trial Services
- comprehensive pre-analysis on study design, choice of endpoints, hypothesis composition, number of subjects needed to reach the required power and stopping boundaries for interim analysis
- advice on and preparation of Study Protocol, Protocol Amendments, Investigator’s Brochure, Subject’s Information and Informed Consent Form, Subject’s Statement, Case Report Forms (CRFs)
- preparation of a complete trial documentation needed for submissions to The Central Register of Clinical Trials (CEBK) and Independent Ethics Committee (IEC) to avoid any delay in initiating a clinical trial
- provision of a clinical trials monitoring services according to standing operating procedures (SOPs)
- performance of a systemic and independent audit examination of trial related activities and documents to determine the fulfillment of all the requirements
- provision of Pharmacovigilance and safety evaluation of the investigational product(s), notification to all concerned investigators/institutions and the regulatory authorities of all adverse drug reactions (ADRs)
- preparation of Final Study Report according to ICH E3 requirements
