Pharmaceuticals - Ahmedabad, Gujarat, India
PHARMA-STATS : Consultancy-Training-Placements Single point statistical solution for Bioequivalence clinical/pre-clinical studies. Large experience in Biometrics. There are many roles we can play and tasks we can contribute to, depending on the needs, experience and availability of your Biometrics staff. -Post study statistical evaluation. It helps manufacturer to better understand their formulations, statistical causes behind the failure of study. -Gives accurate statistical solution at planning stage of study design based on previous studies evaluation to get successive results. -Analysis clinical/pre-clinical data -Protocol preparation -Report Review -Sponsor/Regulatory query response -Expert advice on any query regarding guidelines discussion & submission -Consultant Biostatistician for Data Safety & Monitor Board (DSMB) / Ethic committee PHARMA-STATS is introducing a new concept in training of Pharmaceutical statistics. -Training as per client requirements to their non-statistician employees working in clinical research, quality assurance, regulatory affairs, formulation development, project management & IVIVC for better understanding of clinical studies (BE) from statistical point of view. Training to statisticians in specific areas of Bioequivalence, Clinical Trial (phase III/IV/PMS), Pharmacovigilance and introduction of SAS and other kinetic tools. -Candidates are also enpored to pharmaceutical requirements with hands on approach. We statisticians to read and interpret clinical and statistical data and results. -PHARMA-STATS help evaluate a candidate strengths and trains them based on the skill sets leading to long term stability. Placement of skilled manpower based on requirement specified for Biostatistician needed for Pharmaceuticals & CROs.
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