Clinical Data Management Program + GCP, GDMP - CRI002

Electronic data capture (EDC) and clinical trial information management systems have made an enormous leap forward in their ability to adapt to effectively meet the challenges in today’s dynamic clinical trial environment. Clinical tests are becoming increasingly complex to support growth in the number of new drug molecules entering the clinical trials each year. Approval of the new molecular entities by the regulatory bodies relies heavily on collecting patient data from trial sites. Such complex environments drive the need for trained professionals. To meet this growing need, Clinwell is offering comprehensive training in the cutting-edge technologies of clinical data management. The training is designed to support the entire study lifecycle from business analysis to online data entry, GCDMP and FDA compliant clinical trial database management systems.

The goal of Clinical Research Associate program offered by Clinwell is to develop and train professionals to understand and navigate an array of regulations and policies that pertain to conducting, monitoring and managing clinical trials. The program covers various aspects of a clinical trial from site selection, patient recruitment, choice of the investigator, study conduct, protocols, safety documentations, and study close out.  In addition, the program is designed to cover international regulations. Our students learn from some of the best faculty in the industry who are certified practitioners with deep experience in clinical trials and monitoring and have a wide knowledge of ICH-GCP, GMP, GLP and HIPAA.