Genelife Clinical Research’s highly skilled staff is well-versed in clinical trial operations including monitoring and managing the clinical components of a study. From start-up to close-out, experienced monitors oversee each study’s clinical processes to ensure proper conduct, patient safety, and 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.
Genelife Clinical Operations department specializes in conducting optimized 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 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.
Our ability to identify and recruit special populations in the shortest amount of time is second to none in the industry. Genelife disease surveillance report data bases contain hundreds of thousands of potential subjects in diverse categories to accelerate the process.
Genelife has also established efficient enrollment mechanisms and screening tactics, which reduces the cost of study for the sponsor. Such mechanisms and tactics include referral services, call centers, optimized screening tests sequence, subject retention techniques, etc.
We 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 research procedures as established by Regularly and sponsor’s audits.