Laxai Aventi Life Sciences Pvt Ltd, the Hyderabad-based contract research organisation will conduct a certified course in Clinical Data Management (CDM). The two months full time programme will have a core foundation programme on CDM followed by detailed training in Oracle Clinical and SAS.
The programme would cover fundamentals of CDM, CDISC (Clinical Data Interchange Standard Consortium) standards, drug discovery process, 21 CFR part 11, validation aspects of data management and GCP (Good Clinical Practices) along with data analysis, data management and CDM systems. This would also include soft skill development programme.
"The intend of the course is for creating a supply of quality manpower in CDM to augment our internal needs and also that of the industry", company sources told Pharmabiz. After the completion of the course the students will be given a choice to execute Laxai's CDM projects as employees, the company sources added.
The programme would be held at the company's CDM training facility in Hyderabad. A nominal fee would be charged from the students and professionals. The course is being designed for students and professionals from science, pharmacy, mathematics, and information system background. The certifying authority has yet to be identified, the sources said.
On a query about the training process, the sources said, the candidates would be selected by an interview. Periodic assessment would be done throughout the course based on understanding of various processes and regulations of CDM, ability to use tools, case studies and soft skills. The course is an interactive model wherein candidates would be provided with hands-on experience in different CDM tools.
When asked about what is the demand for trained professionals in CDM segment, the sources said that in an effort to cut down operational cost the mid sized bio-pharma and CRO companies are looking at India to set up their data centres. It is estimated that nearly 90 per cent of the CDM activity can be outsourced. This defines that there are immense opportunities to be taped. To meet even a partial requirement, qualified and trained professionals are in great demand.
Apart from training the company provides a wide spectrum of drug development and clinical data management research services through integrated R&D outsourcing platform. The company has capabilities in medicinal chemistry, process development and optimisation, analytical research (method development and validation), preclinical studies and clinical supplies management, clinical data management services and data standardisation.
For more details about the programme contact: Tel: 040- 30524030-34