Clinical Data Management is a key component in the development of new medications, medical procedures and devices. It is an integral part of a clinical trial. Data management is done in different ways by different people depending upon the focus area and emphasis. A pharmaceutical company or sponsor may have particular interest, research and academic institute may have another. Whatever may be the case; the major role of clinical data management is collection of clinical trial data and ensure that data is error free, consistent and complete.

Data is generated at the clinical trial site and stored in paper form and more recently in EDC (electronic data capture). The site is usually a hospital/clinic where the patients in the clinical trial are recruited and provided the drug treatment as per a well-defined protocol. There are many guidelines and also laws that outline the governance and conduct of the trial to ensure the safety of the patients involved. The clinical trial data gathered at the investigator site in the case report form (CRF) is transcripted in the clinical data management system (CDMS). Some of the popular platforms used globally are Oracle Clinical and Clintrial. The EDC platforms wherein the data is entered directly into the system at the site; include Inform, Medidata and Oracle Clinical. To reduce the possibility of errors due to human entry, the system employs the double data entry to ensure high quality of data in paper-based trials. Once the data has been screened for typographical errors, the data is validated to check for logical errors. The entered data is cleaned, reviewed and extracted to be provided to the biostatisticians for review. At the end of the clinical trial, the data in the CDMS is analyzed and sent to the regulatory authorities for approval.

Clinical data management team works closely with sponsor, sites, clinical operations team, and biostatisticians to ensure that the data obtained is as per the expectation of the statistical analysis protocols.

The role of CDM in clinical trials is still evolving with the emerging technology. The success of any clinical trial project lies in how robust is the processes and infrastructure of CDM facility. Clinical Research Organizations (CROs) are offering partly or complete CDM services. Some of the CDM services offered by CROs are:

  • Case Report Form design
  • Data Management Plan
  • CRF Annotation
  • Database Design
  • Database Testing
  • Entry of CRFs data
  • Edit checks preparation
  • Data validation
  • Lab data loading and maintenance
  • Data cleaning
  • Medical Coding
  • Medical review of data

International developments in CDM:

Globally, we are observing a shift from the traditional paper-based study to electronic version, commonly termed as EDC, electronic data capture. The major reason for this can be attributed to the growth in Information Technology (IT) service sector for Life Sciences. EDC has not only made easier to capture data remotely from various sites but also with inbuilt validation and edit checks it has made possible to collect error free data in the very first stage. EDC systems have also made handling of clinical trial data more secure and efficient. The data from the EDC systems can be exported in various formats like CDISC, XML, etc. With tremendous growth in storage technologies (SAN, NAS), it has become a reality to store terabytes of EDC trail data in a small space securely and in a cost effective way compared to storing large volume of paper documents during traditional paper trials. EDC has also helped in reducing the total time in getting 100% clean data. Earlier the time required to clean trial data was quite high compared to the trial data in EDC. Hence, the data analyses, reporting and submission of trial data to the regulatory agencies is done at much fast pace thereby saving precious time and cost. With many good pharmacovigilance systems and their integration with EDC and clinical data management systems, it is now possible to detect the adverse events, if any, at a very early phase of the clinical trial.

With advent of clinical trial management systems and electronic document management systems (EDMS), it has become possible to share real time information across the globe. This has not only helped in conduct of data management activities more efficiently but also has cut short the time needed for discrepancy management.

Going forward, electronic data capture (EDC) is an emerging trend and a majority of the trials in the coming years will shift to this mode of transfer from the traditional paper based data capture. A hint of who will dominate the market is given by Mr. Mahesh Malneedi, President, MakroCare, who says that ?as more and more trials becomes paperless and move towards EDC, companies that have thorough EDC capabilities will be best positioned to capture market.

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