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 ensure effective and end-to-end project management from start-up to close-out. Our Project Managers maintain personal ownership of study milestones to ensure the projects are successful, delivered on time and completed within budget.

The responsibilities of our Project Managers include:

• Acting as the primary point of contact for our clients and the project team;
• Providing project management plan and road mapping for successful execution;
• Running in-depth feasibility studies and risk assessment plans for country evaluation, including the regulatory environment, disease prevalence, and patient access;
• Creating a timelines framework to optimize project execution;
• Following-up on project risk management;
• Ensuring strict compliance to national standards, ICH GCP guidelines, local regulations, assigned SOPs and the trial protocol;
• Overseeing all functional areas and vendors;
• Managing site and sponsor communication.

Our monitoring services include comprehensive monitoring plans, support for 100% source document verification or risk-based monitoring strategies, identifying and escalating adverse event (AE) issues, routine monitoring, site initiation, interim, and close-out visits, and on-going formal training programs. We operate via local CRAs in each of the countries to ensure that our clients have immediate access to local knowledge, under robust, centralized SOPs.

Our CRAs conduct on-site monitoring visits throughout the study to

• Oversee data collection
• Review source documentation and case report forms
• Ensure regulatory compliance
• Resolve data queries
• Conduct interim analyses as requested by clients

Our independent department with extensive domestic and overseas quality assurance (QA) experience provides audit and QA services.

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.

Our clinical data management processes, expertise and technology are developed to make each step of your clinical trial data management process more accurate and efficient for Phase II-IV in wide range of therapeutic areas.

ClinSite Team is Well-Versed with

• Current Good Clinical Data Management Practices (cGCDMP)
• International conference on harmonization Good Clinical Practices (ICH-GCP)
• 21 CFR Part 11 Compliance
• Health Insurance Portability and Accountability Act (HIPPA) Requirements
• Applicable local Regulatory Guidelines

Our team of medical writers are foreign qualified medical doctors, specialized 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

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 trained CRAs, 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.

We can procure high quality Bio-Specimens whether disease specific or healthy samples including Tissues, Saliva, Serum, Stem Cells, Bone Marrow etc.,

We have access to potential hospital sites and different disease types including Cancer, Malaria, Dengue, HIV, Tuberculosis, Hepatitis, Cardiovascular, etc. We work with certified hospitals / laboratories to ensure our samples are quality checked to meet the needs of our Sponsors.

ClinSite provides clinical laboratory and diagnostic testing services in collaboration with its esteemed affiliated laboratories nationwide, catering to a range of required tests before and during the clinical trial.

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 vendor management services are designed to streamline and optimize the process of managing relationships with external suppliers and vendors. Management of various types of vendors such as

• Clinical trial insurance,
• Translation Services,
• Bio-sample related vendor,
• e-Clinical solution,
• Printing of subject facing material,
• Purchase of clinical trial supplies & medical devices
• IMP Manufacturing and Relabeling.
• Collect and dispose of medical device and IMP

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.