Investigative Site Services

mediSMART partners closely with investigative sites to ensure clinical trials are conducted efficiently, compliantly, and with patient-centric focus. Our site support services are designed to strengthen operational performance at the site level and enhance enrollment outcomes.

Our Investigative Site Services include:

🏥 Site Feasibility and Selection Process

We conduct thorough feasibility assessments to identify high-performing, protocol-aligned sites. Our selection process is data-driven and considers site experience, patient availability, infrastructure, and regulatory readiness to ensure optimal site performance.

👁️ Monitoring Visits

Our experienced clinical research associates (CRAs) carry out regular on-site and remote monitoring visits to ensure protocol compliance, subject safety, and data integrity. We tailor monitoring strategies to fit each study's complexity and risk level.

👥 Subject Recruitment and Site Recruitment Support

We support both subject and site recruitment by developing targeted strategies to accelerate enrollment and minimize delays. From identifying recruitment challenges to implementing outreach plans, we help sites meet enrollment goals efficiently.

🔄 Subject Transfers

We facilitate smooth subject transfers between sites when needed, ensuring continuity of care, data accuracy, and regulatory compliance. Our team coordinates the logistics and documentation required for a seamless transition.

📑 Regulatory Services

Navigating the regulatory landscape is critical to the success of any clinical trial. At mediSMART, our regulatory experts manage submissions and approvals with precision, ensuring full compliance with local and international requirements throughout the study lifecycle.

Our Regulatory Services include:

🗂️ IRB/IEC and Competent Authority (CA) Initial Submissions & Approval Tracking

We prepare and submit comprehensive initial application packages to Institutional Review Boards (IRBs), Independent Ethics Committees (IECs), and Competent Authorities (CAs). We also provide ongoing tracking and communication to ensure timely approvals and mitigate delays.

📨 Regulatory Submissions and Follow-Up During the Study

From site activations to study updates, we manage all regulatory communications and submissions throughout the trial. Our team ensures that regulatory obligations are met consistently, and follow-ups are tracked and resolved efficiently.

✏️ Amendments and Annual Notifications

We handle protocol amendments, investigator brochure updates, and annual safety reports, ensuring that all changes are submitted to the appropriate authorities in a timely and compliant manner.

📦 Substantial Submissions

Our regulatory team is experienced in preparing and submitting substantial modifications and safety-related updates, maintaining alignment with country-specific guidelines and sponsor expectations.