Clinical Trial Data Management : A Career Option for Pharm.D

Dear Readers..!!! Thanks for visiting my blog...!!!

Clinical Data Management:

Clinical trial data management and statistical analysis is one such area which is growing rapidly, whose primary responsibility is to ensure the validity of clinical trial data and format them for statistical purposes. It is the collection, integration and validation of clinical trial data. As the review and approval of of new drugs by regulatory agencies is totally dependent on the quality of trial data the companies has to ensure the integrity and confidence in the results of the trial data.

The management of clinical trial data involves various steps as follows: 

1. Data acquisition/collection
2. Data abstraction/extraction
3. Data processing/coding
4. Data analysis
5. Data transmission and storage
6. Data privacy and confidentiality
7. Data Quality Assurance

Here is the schematic representation of various positions in Clinical Trial and Clinical Data Management in various Multinational Companies

Requirements and duties to be a part of Clinical Trial Data Management: 

1. Data managers also designs collection instruments, sets up databases and tracks and manages the flow of data to and from the investigative sites. 
2. They establish protocol-specific data review and entry guidelines to document data validation and formatting procedures and defines batch-ending programs by monitoring timely data entry. 
3. Reviewing of data discrepancies, resolutions provided by the investigative sites and entry corrections in the database has to be carried out in the data management. 
4. The Clinical Trial Management crew assists in reviewing of interim/final data listings prior to transmission to other groups or inclusion in final reports.
5. Has to be familiar with database management systems and the principles, organization and content of standard Case Report Form (CRF) libraries which ensures the tracking of incoming CRFs in a timely manner prior to safety review and upon manual review.
6. Conducts database audits according to established SOPs and is familiar with the implementation of Good Clinical Practices and should be familiar with data coding of Standard Operating Practices (SOP) and coding dictionaries. 

For more Updates, follow us on Facebook. 

Happy Blogging...!!!

Regards,

Deepak Kumar Bandari,

Pharm.D Intern,

Vaagdevi College of Pharmacy - India

Elsevier Student Ambassador - South Asia