SKILLS

Through knowledge of ICH and Indian (Schedule-Y) guidelines for clinical studies and Module 2 of CTD.
Design of IEC dossier including protocols, informed consent forms (ICFs) case report forms (CRFs), clinical summary for BA/BE and Pharmaco- scintigraphy studies in compliance with GCP.
Preparation of Information Brochure and other regulatory standards and provide conceptual inputs, design, organize and coordinate clinical studies
Theoretical and practical knowledge of radiolabelling and scintigraphy studies of pharmaceuticals (oral and parental preparation).
Pharmaceutical product development (i.e. oral dosage forms, nano particles and nano gel formulations)
Theoretical and practical knowledge of various instruments like HPLC/UPLC, FTIR, DSC, UV spectrophotometer, Different chromatographic techniques, Particle size analyzer, Spray Drier, Flame Photometer, Gamma Counter, Dual head SPECT-CT etc.
Basic knowledge of Kinetica, Graph Pad Prism 5.0, SAS and its applications.
Through knowledge of Dossier preparation, clinical and ethical committee protocol, ICF, CRF writing and clinical trial monitoring.