Preperation & Review of BA/BE Study Protocol, CRF & English ICF.
Provide input for study design, sample size, sampling point, drug specific Inclusion-Exclusion Criteria. Maintaining the records of all agreement with respect to Clinical department.
Verification of bills from vendors. Maintaining the list of pilot & pivotal studies. Correspondence with IEC to obtain approval for clinical study protocol. Co-ordination with translation Agencies for translation of study ICF's.