The Mumbai-based Clinical Research Education and Management Academy (CREMA), one of the major clinical research educational institutions in the country, is planning to commence third party audit (TPA) training programme and services to support the fast growing clinical research segment in the country for quality assurance.
The institute, which is already offering training programmes in a wide spectrum of pharmaceutical segment to equip the companies with skilled manpower, is in very early stage of designing training module for third party audit for various quality related programmes with the international standards. Once launched the training programme, the institution will also enter into selling TPA services, according to Dr S M Sapatnekar, founder director and dean of CREMA.
"We already have a panel of certified quality auditors with us. We are in the process of starting various quality management related training programmes to support the TPA for Indian pharma companies. Once the training programmes are on full swing, we will start selling TPA services for quality management," said Sapatnekar.
With the Indian clinical research industry poised to grow big in the near future, attracting more projects to be conducted in the country by overseas firms, the need for institutions to offer independent reviews and audits of clinical trial investigator sites, research groups, data management audits and sponsor clinical operations, according to the standards set under Good Clinical Practice (ICH-GCP) and international and regional regulatory requirements is higher, Sapatnekar explained.
"With the increase in the number of clinical trials conducted in India by overseas firms, many of the companies are looking for authentic TPAs to conduct audit of their clinical trials in the country. By establishing the TPA services, CREMA would conduct audit for investigational sites, laboratories and clinical research organisations. However, there is no fixed time frame for launching the courses and services," he added.
Similarly, the institution is also all set to offer a range of training programmes in various fields for clinical research, including training for principal investigators in basic good clinical practices (GCP), clinical data management training for non experienced people, training on clinical data management with emphasis on ICH-GCP guidelines, training to register clinical trials with the drug regulatory online and training on pharmacovigilance at a time when the government is tightening the regulatory noose to bring in quality and safety in pharma products dispensed in the country.
"With the global regulatory mechanism becoming stricter day-by-day and new regulations and quality standards are set by the authorities frequently, the clinical research organisations have to keep its manpower updated on each developments regularly to meet the competition. CREMA is always keen in developing skilled manpower with hands-on experience in various fields of clinical research. These programmes are designed to help the industry to execute its clinical research programmes at ease," Sapatnekar said.
At present, the institution is conducting continuous education programmes on advanced GCP, good laboratory practices (GLP) and clinical data management to update the professionals with recent advances in the regulatory norms as per the ICH guidelines. In order to make the classes more relevant, the institution arranges most experienced experts from the industry as faculty for each of the courses, he added.