Clinical Research Organization for Healthcare provides clinical-study and clinical-trial support for drugs and medical devices, wherein many pharmaceuticals, biotechnology, and medical device industries having operations in the Europe Union states outsource research services to CRO to increase efficiency and improve productivity.
Clinical Research Organization | PEPGRA
Contract Research Organization for Pharmaceutical Industry offer services such as Project, Data and Regulatory Management; Contracting; Medical Writing; and Site and Medical Monitoring, which offers the comprehensive benefits for pharmaceutical companies in Europe Union to make clinical research trials more efficient and cost-effective in testing economic period.
CRO industry Challenges
The CRO faces multifaceted challenges in the form of
- Increasingly becoming complex nature of regulatory requirements, GxP compliance, and quality.
- High levels of risk associated with the CRO business model
- Increasing cost of research trials
- Inability of CRO’s to absorb high levels of risk
- Fragmented nature of business and continuous trend towards consolidation
- Variable nature of quality in the business that is influenced by many factors
- Requirement of resource-intensive management
- Decreased cost savings and profitability
- Research personnel changes and losing knowledgeable team members during mergers and reorganizations
- Global/local Competition in terms of price variation
Key attributes in selecting a CRO for a research trial
Sponsoring Pharmaceutical and Medical device companies generally focus on important attributes like confidentiality, quality, cGMP compliance, timeliness, project cost, the reputation of CRO while choosing their outsourcing partner for conducting research trials.
The major criteria for CRO selection can include
CRO structure and financial stability
Factors such as company reputation, structure and their financial condition and their 2 years past record performance are all good indicators to look out for in a CRO while outsourcing clinical trials
Scientific capabilities and Efficiencies
Pharmaceutical companies can outsource research trials to CRO after doing a detailed investigation on their complex skills and specialized competencies in the particular research trial area that is not available in-house.
Service portfolio
Medical Devices manufacturers and Pharmaceutical companies need to choose a quality-driven global Clinical Research Organization (CRO) possessing excellent therapeutic area expertise and experienced scientific and medical writers capable of producing high-quality Clinical Research writing for healthcare. The CRO needs to offer an array of services such as scientific medical writing, physician writing, publication support, biostatistics, and regulatory writing as per the European Union state requirements.
The Medical device companies need to choose CRO that has good capability to produce quality-rich Regulatory writing for class iii Medical Devices essential for getting Premarket approval (PMA) and has extensive experience in preparing Clinical Evaluation Reports (CER), CE-market studies, post-market studies etc.
Quality Assurance audit/review
Quality Assurance (QA) plays a critical role throughout the sponsor company- CRO outsourcing partnership, which helps the healthcare, pharmaceutical and medical device companies sponsoring the research to ensure complete compliance with the Europe Union State-specific applicable GxP requirements.
Thus, the pharmaceutical and medical device companies need to look out for these critical elements while selecting a suitable CRO for their research trials, which can have a significant impact on the realization of their business goals and objectives.
About Author,
Dr. Nancy,
Editor-in-chief,
PEPGRA Healthcare Pvt Ltd.