CLINICAL TRIAL SERVICES
Clinical trial services are research studies that test how well new medical approaches work in humans. These biomedical and behavioural research studies are designed to answer specific questions about new therapeutic products or procedures with the aim of generating safety and efficacy data, data used to support regulatory submissions, and approvals across the globe. Often expensive and complex, these trials represent some of the most significant value enhancements for pharmaceutical and biotech companies. Success relies on good clinical trial services design with effective and efficient execution. Delays and failures are costly. They can significantly impede the availability of new and innovative products that may improve life for patients and their families.
BioAgile Therapeutics Pvt. Ltd. headquartered in Bangalore, India provides expert clinical trial operations (CTO) services to the pharmaceutical and biotechnology industry. Our CTO staffs are skilled in clinical trial management, clinical monitoring, expedited study start-up, patient recruitment, and the execution of study feasibility assessments. Bio Agile Research prides itself in being able to skilfully execute the vital operational best practices needed to ensure that your trial is conducted according to your time, quality, and cost objectives.
Clinical Trial Management
To ensure that your study is executed in the time frame you require and with the quality expected by regulatory agencies, our clinical study managers will partner with you every step of the way. Our study managers will map out operational objectives that are likely to have the most direct and most significant impact on the time, quality, cost, and outcome of your program. Using state-of-the-art best practices, our study managers will lead your dedicated project team and ensure that your clinical trial management remains well planned and executed throughout the project life cycle. Key focus areas include efficient study start-up; strategic patient recruitment; high-quality yet efficient trial operations; proper trial operations decision making and documentation; and strong clinical research associate (CRA) leadership and oversight.
Our CRAs are an extension of you. We are sure you will agree that they are positive, professional, thorough, and articulate. Our CRAs are experienced at working effectively with sites to ensure that our patient recruitment and study execution goals are met. Bio Agile clinical monitoring services include traditional, full-service monitoring, as well as risk-based and centralised monitoring services, depending upon your goals and the needs of your project. Both office-based and regional CRAs are available for assignment to your project.
Study start-up is one of the key cost drivers in your program. Experienced decision-making in the areas of study site selection, required essential document collection, and investigator contract negotiations can make or break your timeline. Bio Agile has study start-up specialists, including dedicated contracts and budgets experts, who ensure that your study is started and enrolling as quickly as possible.
We understand the challenges and importance of a successful patient recruitment program. We take a proactive approach to develop a strategic enrolment plan that is patient centric, data driven, and site specific. Our dedicated team builds a strong relationship and nourishes loyalty and trust with the study sites. Combined with a passion for engaging patients as study partners, we empower sites to enroll the appropriate patients in your study in the shortest time possible.
Our feasibility assessment team will collect and summarize valuable, detailed feedback from clinical research sites to support critical decision-making in your clinical development program. We will help determine important parameters such as patient enrolment rate, number of sites needed, local standard of care, viable patient assessments, potential study challenges, and investigator grants. Our goal is to collect the specific site feedback needed to make your study a success. The information our team gathers is summarized in a feasibility report with key recommendations.