Clinical Research Operations

• We manage simple and complex clinical trials.

• Site feasibility assessment

• Site selection

• Handling all site related activities and monitoring work

• Complete responsibility of clinical Data management process for multiple clinical trials.

• Data analysis and reporting.

• Database quality checks and data validation.

• Data Analysis, Data Mining & Secondary Research.

• Acquisition of data from internet, Case Report Forms (CRFs) & Data Clarification Forms (DCFs)

Back office & Data curation

• Collect & analyze the information about marketed & development stage products of Pharmaceutical companies including clinical trial data, regulatory information (approvals & filings of NDA, BLA etc), press release tracking & analysis, Deal-M&A (mergers & acquisitions), patent updates capture for products & companies from various secondary sources like company websites, regulatory sites, Clinicaltrials.gov, SEC filings, annual reports, scientific journals, healthcare conferences and annual meetings like ASCO, ASH, SABCS etc.

• Wide variety of public & proprietary data bases: FDA, EMEA, ClinicalTrials.gov, NCI, CTRI, UMIN, Medscape, PubMed, Science Direct etc for trial related information of patients like patient segment, therapeutic area, target accrual, actual accrual, status of a trial, study design, inclusion and exclusion criteria, information of investigators involved etc.

• Construct records for clinical trials conducted all over the world and extract out information from various therapeutic areas' annual meetings, journals, company registries, company press releases and countries registries.

• Data entry of Phase II-IV clinical trials.

• Perform web search of various clinical trials on various criteria that we follow in our work-process and assemble the data thoroughly and with high precision.

• Manage your content writing, literature, social media.