April 27, 2010
Edc Cdisc Clinical Data India
Clinical Data Management system is a key component in the development of new medications, medical procedures and devices. It is an integral part of a clinical trial. Different people depending upon the focus area and emphasis do data management in different ways.
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 ensures 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, extracted and 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.
Electronic Data Capture- The Future
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. Earlier the time required to clean trial data was quite high compared to the trial data in EDC. As the volume of information collected in clinical trials continues to grow, data collection and management is becoming a priority for pharmaceutical companies and clinical research organizations. One of the critical component in clinical trials is Capturing data which is more accurate and in time to market for potential new drugs.Electronic data capture (EDC) systems are used in all phases of clinical trials to collect, manage, and report clinical and laboratory data.
Electronic data capture (EDC) provides both the tools and the process infrastructure necessary to achieve the needed data quality as well as process scalability
MakroCare, a multidisciplinary knowledge and technology driven clinical research organization (CRO) that offers CDM (paper and Electronic) and EDC Services and many more. It does the data analyses, reporting and submission of trial data to the regulatory agencies in much fast pace thereby saving precious time and cost.
