News Facts
• 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 organisation, 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 organisations 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.
• Oracle’s clinical development applications have been deployed across many clinical trials, including studies across all development phases for many therapeutic areas and vast patient populations in multiple geographies. Oracle clinical development applications are designed to provide maximum system uptime and availability to ensure continuous operations and security of clinical data.
• With Oracle Clinical, PPCE will 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.
Supporting Quotes
• “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% of clinical research spend and 18% of total R&D spend,” said Khushnoor Dastoor, Executive Director, PPCE. “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 fulfil our biopharmaceutical drug development requirements across the globe”.
• “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,” said Neil De Crescenzo, Senior Vice President and General Manager, Oracle Health Sciences. “PPCE’s combination of broad coverage and deep functionality will help it better address clinical data management and help them boost business productivity and ROI with each clinical study.”
Supporting Resources
• Oracle in Health Sciences
• Oracle Clinical
• Clinical Research Allied Services – Phoenix Progressive Certification Enterprise Ltd.
