CLINICAL OPERATIONS - 'From Molecule to Drug'

Provenance's Clinical Operations department has a highly motivated team of well trained professionals with global Investigational New Drug (IND) studies exposure and Multinational trials exposure in various therapeutic areas covering from Central nervous system, Respiratory disorders, Endocrine disorders Oncology, Gynecology, Cardiology and Infectious diseases, Provenance helps our clients conduct:

• Proof of concept studies
• Phase II - IV studies

Our objective for conducting clinical studies is built on our strong core values to maintain the highest standards of ethics, quality and confidentiality which will attract the India's and world's best drug discovery and development companies.

Provenance with its extensive expertise and resources will help you plan and manage your trials from beginning to end, from study design and feasibility to patient recruitment, clinical monitoring, database design and document management, statistical analysis and reporting, medical writing and, protocol development, and Pharmacovigilance. Our expertise will ensure study timelines are adhered to ensure no loss of revenues to our clients. We promote a team approach with an emphasis on management, support, recognition, training, accountability and personal development. To ensure our clients receive quality monitoring services, we provide our Clinical Research Associates (CRAs) with a comprehensive training and development program to ensure compliance with applicable guidelines.

All projects are efficiently executed by project Leads who have rich experience in conducting and handling international standard studies. Qualified and experienced CRAs trained in ICH GCP guidelines and relevant national regulations to oversee activities at trial sites. This structure combined with a proactive plan for issue identification and resolution provides a flexible and responsive approach for successful clinical trial completion within specified timelines. Protocol-related questions and other safety or clinical concerns are addressed through the close collaboration of project managers and medical monitors, ensuring the integrity of clinical trial data. Provenance also has resources with expertise in conducting and managing Investigators meeting both in India and Abroad.

Provenance's Clinical Operations team selects each clinical site based on various parameters like access to specified patient population, meeting infrastructural requirements, previous experience in specified indication and trials, a recruitment and retention plan unique to each site is prepared, focusing on the site's strengths and past successes. Provenance's teams of Mangers and CRAs have well-established relationships with clinical sites and will work closely with each site to develop successful recruitment and retention strategies.

Site management also covers upgradation of site infrastructure to meet clinical trial requirements. Provenance is committed in developing new investigators and training them to enrich the investigator database in different therapeutic areas. Site finance management and Budget negotiations is also a core activity of the Clinical Operations department.

Provenance understands the importance of skilled and eligible monitors to oversee and ensure appropriate conduct of clinical trials, and hence has handpicked the best CRAs with vast experience in handling trials of complex and global nature.