Vedum clinical research pvt. ltd. expertise in medical and life science translation and language services provides the quality, efficiency, and reliability necessary to compete in this fast-paced industry. From our knowledgeable client service staff to our linguists trained in biomedical terminology, Vedum provides full clinical trial support including processing of trial sample documents, report evaluations, and data management and preparation for approval.

Vedum has the specialization, experience, and resources to cross new boundaries with your global clinical trials.

• Case Study Report Forms
• Clinical Study Protocols
• Clinical Study Report Forms
• Informed Consents
• Patient Diaries/Forms/Materials
• Preclinical - Phase IV Documentation
• Quality of Life Scales and Questionnaires

Vedum’s medical writing services include clinical and regulatory writing, as well as scientific communications, education material and medical writing consultancy. Examples include:

• ICH GCP compliant Clinical Study Reports (CSRs); Phases I to IV, including CSR Synopses for public disclosure
• Study Protocols
• Investigator Brochures
• Patient Safety Narratives
• Patient information including Informed Consent and Patient Brochures
• Pharmacovigilance documents such as Periodic Safety Update Reports
• Standard Operating Procedures (SOPs) covering all aspects of drug development including the design, conduct and reporting of clinical trials.

Vedum Research appreciates the significance of high quality submissions to the relevant Regulatory Authorities to ensure that approvals are available in a timely fashion. We have experts on the ground who have the required up-to-date knowledge of the regulatory submission process, specific to the country.

In many cases, our team will undertake the Ethics Committee submissions to make sure that the process is seamless from gaining approval to study start-up. Our team members have a thorough practical knowledge of completing Ethics Committee and Regulatory Authority Submissions.

Our teams have successfully completed submissions in some of the most challenging regulatory environments and have a comprehensive understanding of the intricacies of each process which gives them the ability to communicate effectively with the relevant agencies and bodies.

In addition to this we help to clinical research sites to register and re-register their respective ethics committee with DCGI and also helping them to get NABH accreditations.

Vedum Clinical Research Pvt. Ltd. performs site management services to act as the liaison between the site, the sponsor and the conduct of the study. We do this by continuous communication with every study site, starting with the collection of regulatory documents and continuing throughout enrollment, follow-up and project completion.

Vedum Clinical Research Pvt. Ltd. understands that site training is key to ensure proper study conduct, quality data collection and to keep our sponsors’ projects on top of the to-do list.

Our proven comprehensive site support model involves placing a full-time, highly qualified clinical research coordinator at each study site to assist the investigators and site staff with all day-to-day study conduct activities. In addition, weekly teleconferences are scheduled with the site throughout the project that allows our staff to review study status, CRF and query completion and assist with protocol questions and any other study related activities to ensure the study proceeds in a timely manner. Vedum Clinical Research ensures all study information is current, prioritized, and available to Sponsors for effective site management.

We effectively address all the training needs of our investigators by organizing ongoing and refresher in ICH GCP, Schedule Y and trainings required for effectively conducting a trial. Besides, we organize outside training on a regular basis to keep both our staff and investigators abreast of all latest trends especially in technology in order to hone their proficiency.

Our project manager accessible at any time during the conduct of the study. Their involvement begins with the proposal and continues through evaluation and selection of qualified sites, study conduct study monitor and right up to the “last project value.” We believe this dedication and insight can only come from our depth of therapeutic expertise and is core to ensuring rigorous management and mitigation of clinical trial risks.

1. Preparation of study materials such as the protocol, case report forms, and informed consent documents

2. Preparation of Project Management Plan, Monitoring Plan, Safety Management Plan. Investigational Medicinal product management (IMP) Plan

3. Establishing necessary documentation for IRB and/or Ethics Committee approval

4. Preparation and support during initial meetings with the FDA and other regulatory bodies

5. Pre-investigational visits to train site staff on the protocol, study materials, applicable regulations, and Good Clinical Practice.

6. Study Monitoring as per the ICH GCP and as per current regulatory guideline

6. Frequent reports and communications to keep you apprised of data accrual and quality on a site-by-site basis, and to assist in keeping the study team on track

8. Study closure and documents archival as per ICH-GCP and regulatory guideline

Once a clinical trial is complete and reports are finalized, we can provide the Sponsor with the Trial Master File. Different regulatory jurisdictions have distinct requirements on the archiving of the Trial Master File and data collected during the clinical study, with some regions requiring archival as per regulatory requirements.

Vedum offers archiving as part of clinical trials to comply with regulations, taking the burden off you to hold these hard-copy documents securely for long periods of time. We use a globally-recognized, third-party vendor to keep your records securely for years to come.