Phoenix Progressive Certification Enterprise (PP CE), a company providing management system certifications like ISO9001, ISO 14001, OHSAS 18001, ISO 22000 and GMP to various industries, has tied up with Oracle Clinical to align its Clinical Research Allied Services with international regulatory compliance requirements.
The tie up will help it to address the growing demand for clinical research services, the focus area of the company, from customers nationally and internationally, said the PPCE officials in a press release. 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.
"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," said Khushnoor Dastoor, executive director, PPCE. He added that 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.
"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.
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. Oracle is the a global firm with complete, open, and integrated business software and hardware systems company.