PPCE picks Oracle Clinical for compliance

NEW DELHI, INDIA: To address the growing demand for clinical research services from customers nationally and internationally, Phoenix Progressive Certification Enterprise Ltd. (PPCE) has selected Oracle Clinical to align its Clinical Research Allied Services with international regulatory compliance requirements.

PPCE, a 14-year-old organization, was established to extend verification and inspection services to land-based and offshore industries, and has since emerged as a functional service provider of choice for its project management skills, service quality, response times and skilled human resources.

Its customers include organizations across the public and private sectors like oil & gas, construction, financial services, utility, transportation, engineering, service providers as well as health sciences including pharmaceuticals and clinical laboratories, said a press release.

“India is one of the fastest growing clinical research destinations with a growth rate that is 2.5 times more than the global market. In India, clinical allied research services accounts for 35 per cent of clinical research spend and 18 per cent of total R&D spend,” said Khushnoor Dastoor, executive director, PPCE.

He added, “We chose a market leading solution like Oracle Clinical to offer our customers with world-class services. In the future, we are looking at adding Oracle Remote Data Capture for EDC studies and Oracle Argus for pharmacovigilance to fulfill our biopharmaceutical drug development requirements across the globe.”

With Oracle Clinical, PPCE would be able to offer its health sciences customers enhanced design protocols and amendments, as well as specify how patient data is tracked. The protocol design includes study objectives, investigator and site information, enrollment plans, drug treatment regimens, randomization schedules and visit definitions. The solution also allows amendments to be inserted transparently, within minutes and with no recompiling or copying.

Neil De Crescenzo, Senior Vice President and General Manager, Oracle Health Sciences said, “Oracle Clinical was built based on the experience of hundreds of companies that conducted clinical trials, which provides us with a greater understanding of clinical data management.”