Clinical Data Management
India has developed into a super power for IT skills and has become a major hub for pharmaceutical and biotech manufacturing and contract research, the outsourcing business in various other segments is also exhibiting promise. Clinical trial data management and statistical analysis is one such area which is growing rapidly, accompanied by a variety of players entering into different models of this business. The author reflects on the data management business in India and reviews the emerging outsourcing models in this growing industry. He has also attempted to work out a break-even analysis considering the projected investment on high quality and costly infrastructure like; hardware, software and human resources to augment the business and regulatory requirements of the industry.
Clinical Data Analyst/ Manager
Primary responsibility is to ensure the validity of clinical trial data and format them for statistical purposes. Also designs collection instruments, sets up databases and tracks and manages the flow of data to and from the investigative sites. With supervision, establishes protocol-specific data review and entry guidelines to document data validation and formatting procedures and defines batch-ending programs. Monitors timely data entry. Reviews data discrepancies resolutions provided by the investigative sites and enters corrections in the database, as appropriate. Assists in the review of interim/final data listings prior to transmission to other groups or inclusion in interim/final reports. Is familiar with database management systems and the principles, organization and content of standard Case Report Form (CRF) libraries. Ensures that incoming CRFs are tracked in a timely manner prior to safety review and upon manual review. Is familiar with data coding of Standard Operating Practices (SOP) and coding dictionaries. Conducts database audits according to established SOPs and is familiar with the implementation of GCPs.