Clinical Site Operations

Clinical Site Operations

Our expert site management organization supports investigators in reviewing source documents, improving accuracy, completeness, and standardization. We provide end-to-end solutions for site selection, feasibility, enrollment forecasting, site activation, patient recruitment, and trial management to ensure successful clinical trials.

Site Selection

Efficient shortlisting of prospective Investigators from our database.

Work with sites for Pre-initiation and prepare them for trial-related activities.

Evaluation of sites based on the patient pool, investigator's area of expertise, and connectivity to the site.

Network of the top enrolling sites nationwide on multiple studies by virtue of their inherent merits.

Sites well equipped with infrastructure and logistics required for clinical trials.

Feasibility & Enrollment Forecast

Efficient site selection after a reliable feasibility data analysis.

Short turnaround time with feasibilities.

Site Start Up Activation

Complete site setup and startup solutions.

EC submissions and approvals.

Contract management.

Document collections.

Site Management Enrollment

Use real-world data and analytics to develop more precise study plans and select sites based on their target patient population density.

Data-driven model to optimize patient recruitment that allows us to alternate recruitment channels for the most efficiency.

Patient Recruitment & Retention Strategies

Strategic planning of recruitment based on protocol requirement.

Assisting sites in organizing health camps.

Patient referrals through peripheral centers from tier II & tier III cities.

Patient retention programs.

Patient reminder calls & letters.

Physician referral letters.

Advertisements when applicable.

Trial Management

Clinical Trial Agreements as per projected study budget and review.

Infrastructure provisioning.

Efficient coordination of the logistics.

On-site developmental briefing of Investigator and the research team.

Streamlined and expeditious start-up and completion of studies on schedule.

Maintenance of CRFs, Informed Consent Forms (ICF), and study logs.

Timely resolution of queries which help the sites to generate clean & legible data.

Excellence in on-site coordination and monitoring of Phase II, III, and IV clinical trials.

Trial-related documents archival and maintenance.

Site Performance Execution

An appropriate execution of protocol.

Follow up and query resolution and thus save our clients' precious time.

Assist in Ethics committee submissions & follow up.

Coordinate logistics management at sites.

Real-time communication by the CRC with sponsor or CRO brings in the connectivity with the site.

QA & Audits

We aim to manage every component of the workflow optimally & achieve results targeted by the Sponsor’s requirements and expectations.

We guarantee data reliability & accuracy through integrity, quality control, internal auditing, and training.

Support in preparation and facing Sponsor’s as well as Regulatory Audits and Inspections.