Our clinical operations team is highly experienced and trained in effective site management services, ranging from feasibility study to study close-out. Collectively, the team has solid experiences in several therapeutic areas. We ensure and always emphasize on the best clinical services, highest ethical standard and quality clinical data. Our Team is thoroughly trained in our SOPs, that meets the international standards. We are dedicated and ready to face all the challenges in the most complex journey of Drug Discovery, Clinical Trial, by taking it successfully through the crucial stages of obtaining the regulatory & ethics committee approval, study initiation, monitoring and study close-out.

Project Management:

It is our constant endeavor to meet or exceed client expectation in achieving the ultimate objective for their clinical development program. Our Project Management team comprises of experienced and trained CRAs headed by Project managers. Our constant focus is on providing quality deliverables, sticking to time-lines and proper budget management. Integrity of the clinical trial data is guarded & ensured by providing top-notch training to all the personnel involved in the study and effective quality assurance process.

Feasibility & Selection of Sites:

• Maintaining Investigator database.
• Site infrastructure to meet study specification.
• Investigator's qualification, interest, experience and prior ICH-GCP trainings.
• Availability of site staff with adequate qualification and experience (ICH-GCP trained).
• Adequate patient pool to follow the most stringent timeline.

Ethics Committee Submissions:

• Ethics Committee submissions as per their SOP.
• Query resolution, tracking submission and obtaining approval.

Study Site Initiation:

• Adequate training of the Investigators and site staff in aspects of ICH-GCP, protocol specific requirements, IP storage, dispensing and accountability, randomization, unblinding of coded envelopes, Source documentation, CRF completion guidelines and data archival.
• Implementation of successful patient recruitment & retention strategies.

Study Site Monitoring:

• Checking ICF documentation.
• 100% Source data verification.
• Monitoring internal consistency of the CRFs/eCRFs.
• Tracking IP accountability and storage.
• Tracking of patient recruitment and retention.
• Integrate telephone, email, fax and regular mail communications with the site.
• Medical monitoring.
• Data query management & issuing data alerts to CDM.

Study Site Close-out:

• Archival and storage of data and information in an appropriate, secure and readily retrievable manner.
• IP accountability and final reconciliation.
• Serious Adverse Event (SAE) reconciliation.
• Reconciliation of study logistics related issues and retrieval of study supplies.
• Reporting study close-out to Institutional Review Board/ Independent Ethics Committee (IRB/IEC) and Regulatory Authorities as per regulatory norms.
• Laboratory Services.
• We have partnered with one of India's premier clinical pathology lab to support clinical studies in international standard. Our partner lab is certified / accredited by College of American Pathologists (CAP) National Accreditation Board for Testing & Calibration Laboratories (NABL) Centre for Disease Control (CDC) and ISO 9001:2000. It has collection centers across the country; sample collection and shipment to the main lab can be done within the minimum time. The variety of test menu offers more than 1500 tests.
• State-of-the-art modern instruments & technology, facilities and quality services gives them an edge of leadership. With the advantages of our partner labs, we provide the same end to end laboratory services for our clients.