Ashok Kumar U Email & Phone Number

Bengaluru, Karnataka, India

Clinical Data Management

Bengaluru, Karnataka, India

Bengaluru, Karnataka, India

Bengaluru, Karnataka, India

Bengaluru, Karnataka, India

Bengaluru Area, India

* Scientific and Competitive Intelligence: Expertise in secondary research, use of databases to mine information, preparing deliverables such as company reports, therapy area reports, trial maps, and pipeline analysis reports.* Building indication and non-indication specific detailing for specific disease trials through secondary research* Analyzing the clinical trial protocols for the patient segment involved inclusion and exclusion criteria in the trials* Secondary Research on investigational products and updating their mechanisms of action, clinical data and verifying their INDA, NDA, ANDA, and SNDA filing status if available* Providing competitive analysis for drugs based on the Patient segment focused, various pipeline and approved products for a specific therapeutic area and based on endpoints to be met* Mapping the results for completed and terminated trials by secondary research which describes safety and efficacy outcomes of the trials* Updating information on daily basis by analyzing Pubmed abstracts, recent Conferences and Journal articles related to specific therapeutic area* Analyzed safety and efficacy parameters from the Phase 1- 4 trials, journals, abstracts and results from the company websites* Advise data management staff on trial parameters, database designs, and validation of critical data* Analyzing clinical trials Competitive landscape from secondary sources like Clinicaltrials.gov, WHO, ANZCTR, UMIN and various other countries clinical Trial registries.* Working in accordance with Indegene SOPs and the customer's requirements.* Performed QC review of documents.* Trained Co-Workers and Fresher’s with detailing the parameters of Indications handled* Prepared overview for Indications handled and presentations done on the latest drug information and FDA approvals