Regulations Pertaining to Clinical Research & Clinical Management Programs
The requirements for clinical management programs (processes for managing clinical trials) stem from regulations and standards such as the U.S. FDA's Good Clinical Practice (GCP) regulations, a group of regulations pertaining to various aspects of executing clinical research.
The International Conference for Harmonization (ICH) has developed a number of GCP guidelines for designing, conducting, recording, and reporting clinical trials for new medicines. They can serve as a framework for a clinical trial's clinical management program. The GCP guidelines were developed with consideration of the current practices of the European Union, Japan, the United States, and other countries and health organizations.
For medical device manufacturers worldwide, ISO 14155:2011 (Clinical Investigation of Medical Devices for Human Subjects: Good Clinical Practice) offers international standards for clinical management programs. Specifically, it offers guidelines for protecting the rights of patients and defining the responsibilities of sponsors and clinical investigators.
Clinical Research & Clinical Management Programs: Common Challenges
It takes up to 15 years on the average to develop a new medicine and about 10 years to develop a new medical device. Sponsors, CROs, and other stakeholders face numerous challenges during that long period of development. A good clinical management program is critical in meeting clinical research challenges such as:
- High Cost of Clinical Research: A report by Cutting Edge Information, a life science research firm, showed that the clinical-trial cost per patient has risen 70 percent between 2008 and 2011. Phase IIIa and Phase IIIb costs were over $40,000 per patient during the 2008-2011 period compared with about $25,000 per patient before 2008. Given the high cost, clinical management programs that promote efficiency and ensure high quality of clinical trial processes are more important than ever.
- Voluminous Documentation Required: Regulatory agencies evaluate a clinical trial by reviewing all essential documents found in the Trial Master File. The TMF typically contains thousands of documents coming from various stakeholders, including the sponsor, CROs hired by the sponsor, and the clinical investigators. Sponsors and CROs are increasingly using electronic platform for the clinical management programs they use during clinical research to facilitate document exchange and collaborative endeavors.
- Disparate Efforts from Different Stakeholders: The ability to unify disparate efforts by different stakeholders is key to the success of clinical research. This includes collaborating closely throughout the life of a clinical trial. For example, time is of essence when dealing with serious deviations; any delay in addressing such issues increases risk. Timely communication and prompt action by the investigators and other stakeholders should be a key consideration in establishing a clinical trial's clinical management program.
Using MasterControl for Clinical Trials and Clinical Management Programs
To address the challenges mentioned above, many pharmaceutical and medical device companies have turned labor-intensive processes during clinical trial into effective clinical management programs by automating the processes. The MasterControl Clinical Suite™ is a complete clinical trial software solution designed to streamline and manage documents, tasks, processes, training, and audits throughout the clinical research.
MasterControl can help in the following areas:
- Clinical Site Management: MasterControl greatly improves a clinical management program by managing site-specific documents (e.g., site qualification, protocol amendments, study updates, etc.). It manages information pertaining to study site selection criteria and site capabilities, as well as investigator documentation and IRB documentation.
- Clinical Processes Management: MasterControl streamlines deviation, CAPA, and other processes critical to GCP compliance throughout the life of a clinical trial. It offers flexibility in creating forms and checklists for managing GCP processes.
- TMF Document Management: Automating clinical management programs for clinical trials means greatly improving TMF document management. MasterControl includes the Reference Model-TMF JumpStart, based on the Drug Information Association's (DIA) Trial Master File Reference Model. It provides a single, web-based location for all TMF documents, making search, retrieval, and tracking of documents easier. GCP Training: In choosing software for your clinical trial's clinical management program, choose one with robust GCP training features. MasterControl streamlines the training process by automating notification of training tasks, dissemination of training materials (documents, audio, video), and testing. It offers configurable questionnaire, test, and quiz setup.
Contact Master Control for Clinical Management Programs
To learn more about clinical management programs, feel free to contact MasterControl representative today.