ClinSite ensures that clinical trial sites adhere to relevant protocols and comply with GCP standards, leading to faster start-up times swift patient recruitment, precise documentation, and shorter study durations.
We leverage country-specific expertise to optimize efficiency in trial site selection, patient recruitment, and retention, ultimately saving time. Our network encompasses a range of sites, including general hospitals with various specialized departments such as gastroenterology, cardiology, infectious disease, neurology, endocrinology, and others.

A) Site Selection > Project Feasibility Study > Site & Investigator Information > Enrolment Progress Assessment > Site Assessment Report

ClinSite has contributed to the establishment and approval of GCP-compliant clinical trial sites having dedicated Clinical trial Units (CTUs). We aim to grow the pool of investigators and sites, leveraging the extensive experience of our alliance network sites across all therapeutic areas.

We offer a rapid and complimentary feasibility assessment for Sponsor/CRO requests through our extensive alliance network of clinical trial sites. Following Sponsor and protocol specifications, our expert team conducts a comprehensive 360-degree evaluation and identifies GCP-compliant sites for the project. A detailed site selection assessment report is then provided to the Sponsor.

B) Project Management > Set-Up > Start-Up / Close-Out

ClinSite ensure effective and end-to-end project management from start-up to close-out. Our dedicated Project managers are responsible for the supervision and management of all sites in the country.

Our project management team conducts ongoing internal monitoring to ensure the accuracy of source data and minimize protocol deviations, fostering a collaborative culture among the study team, sponsor, CRO, and SMO.

Our team ensure the following deliverables during various stages of the project

ClinSite assists in reviewing and completing all study documents, including localizing the Informed Consent Form (ICF) to meet site-specific and local regulatory requirements, as well as reviewing and finalizing Investigational Medicinal Product (IMP) labelling in accordance with local regulations.

Our experienced regulatory team gathers the necessary documents, as per the checklist provided by Local Ethics Committees (LEC), Central Ethics Committees (CEC), and Regulatory Authorities (RA), to compile and submit dossiers to the relevant authorities. We also handle queries and correspondence with regulatory authorities to ensure timely resolution and robust approval.

ClinSite provide support to participants in accurately understanding the complete clinical trial and its process in its native language. Additionally, we oversee participant recruitment rate at clinical trial sites, and if needed, provide sites access to a broad network of referral recruitment through clinics, doctors, and satellite sites.

ClinSite provides a diverse workforce, offering expertise in various therapeutic areas, skill sets, and experience levels to meet the needs of clinical trial projects for CROs, sponsors, and clinical trial sites, whether for short-term or long-term engagements

• Clinical Research Coordinators
• Study Nurses
• Study Coordinator
• Project Managers
• Project Administrators
• Project Management Assistants
• Quality Assurance
• Regulatory Affair
• Database Administration
• Healthcare Specialist/Physicians
• Medical Writing
• Medical Affairs
• Drug Safety and Pharmacovigilance

At ClinSite, our team of professionals specializes in conducting thorough feasibility assessments to anticipate potential hurdles in advance, thereby guaranteeing the optimal design of every clinical trial for success. We engage in comprehensive discussions with investigators and sites to gauge early feasibility, assessing factors such as investigatory alignment, investigator engagement, patient accessibility, enrolment projections, and study site capabilities.

ClinSite handles payments to the clinical trial sites and patient inconvenience allowance, thus, making it convenient for the Sponsor to check accurate invoicing against relevant activities and expense, calculating site fees, and processing payments in accordance with local tax requirements. This is achieved through the implementation of a service acceptance certificate, ensuring accuracy and compliance.

ClinSite offers training sessions on protocols, study procedures, and local as well as international regulatory guidelines, ensuring compliance and authenticity in conducting clinical trials.

ClinSite offers trial sites assistance in archiving and maintaining trial-related documents, storing trial documentation for a specified duration according to local Standard Operating Procedures (SOPs), Sponsor directives, and Regulatory Authority (RA) stipulations.

ClinSite offers temperature-controlled storage and distribution services for Investigational Medicinal Products (IMPs), comparators, and consumables to clinical trial sites within a cold chain environment (2-8°C).

ClinSite facilitates the export of biological samples (serum) through our specialized service providers, who have over 30 years of experience in exporting biological samples worldwide.

ClinSite oversees the acquisition and distribution of clinical trial supplies, including necessary technical equipment for trial execution. We also assist sponsors in procuring and distributing concomitant medications from trustworthy and authorized sources essential for the clinical trial.

ClinSite assists sponsors in having the Investigational Medicinal Product (IMP) manufactured at a GMP-certified facility with expertise in producing IMPs for experimental use. Additionally, we provide re-labelling services for both the IMP and comparator through a facility certified in GMP and experienced in IMP manufacturing/relabelling.

ClinSite has established partnerships with certified translators to provide translation services for essential participant facing documents in the vernacular language.

ClinSite has established and upholds a quality management system in alignment with the ISO 9001 standard, covering all operational facets. This system encompasses quality assurance and control, risk assessment, process monitoring, training protocols, work permits, and routine personnel evaluations.

The well-being of participants is paramount in clinical trials, and timely safety reporting to investigators, sponsors, and regulatory bodies is crucial to ensure this. Our clinically trained CRCs, certified in ICH-GCP, are deeply committed to ensuring prompt notifications and submissions.

ClinSite adheres to pharmacovigilance practices aligned with guidelines such as ICH E2A “Clinical Safety Data Management: Definitions and Standards for Expedited Reporting,” E2F “Development Safety Update Report,” and local regulations.

Our team of medical writers consists of specialists with both scientific background and therapeutic knowledge.

• Protocols and protocol amendments
• Informed Consent Forms
• Clinical Study Reports
• Investigator Brochures (IBs)
• Clinical expert reports
• Scientific manuscripts
  • Manuscripts
  • Abstracts
  • Publications

Our incineration services provide destruction of clinical trial medication and supplies at a cost-effective price throughout our network of incineration facilities according the acceptable procedure by regulatory authority.

ClinSite facilitates sponsors in obtaining fast-track Emergency Use Approval (EUA) and Marketing Authorization (MA) for their research products. We also assist our Sponsors to identifying a reputable exclusive pharmaceutical / biopharmaceutical company for sales & marketing in the country.