Clinical operations requires execution of Protocol, SOPs, strategies, plan, GCP and regulations for successful completion of project. The trained and skilled staff of Clinical operations department is well-versed in clinical trials activities. In co-ordination with project management team they monitor timely execution of Project.
The CRA/monitors of Genelife manage the clinical components of study at site and at Genelife. From site selection to database lock, our experienced monitors oversee each clinical processes to ensure timely and proper conduct of study. They also ensure patient safety, data quality, while fostering good communication between study sites and sponsor. We offer a wide network of experienced monitors throughout India, Europe and the USA. Today’s requirements for global development programs are served by our alliance with long-established partners in Australia, China and South Africa.
Our Clinical Operations team specialises in conducting optimised Pilot and Phase I, Phase II and III Pivotal ANDA and 505(b)(2) NDA studies. These trials have resulted in successful filing for ANDA, 505(b)(2) and 505(b)(1) NDAs. Genelife´s operations department performs following functions:
- Study document Management
- Resource management and quality control
- Monitoring and Control
- Clinical trial management system
- Audits and preparation for Regulatory audits
- Patient recruitment and retention strategies
- Worldwide feasibility studies
- Tailor made clinical services
Genelife clinical Research has significant experience in conducting site monitoring. An onsite monitoring will address regulatory compliance, subject informed consent, drug accountability, and comparison of selected CRF data against source documentation.
Genelife Clinical Research ability to identify and recruit special populations in the shortest amount of time is second to none in the industry. Genelife Clinical Research disease surveillance report data bases contain hundreds of thousands of potential subjects in diverse categories to accelerate the process.
Genelife Clinical Research has also established efficient enrollment mechanisms and screening tactics, which reduces the cost of clinical trials for the sponsor. Such mechanisms and tactics include referral services, call centers, optimized screening tests sequence, subject retention techniques, etc.
Genelife Clinical Research have close interactions with hundreds of oncology, cardiovascular, CNS, dermatology, gastroenterology, ophthalmology, and other therapeutic area doctors not only for fast recruitment, but also for maintaining the highest quality clinical trials procedures as established by Regularly and sponsor’s audits.