When you conduct a Clinical Study at Vedic Lifesciences Pvt. Ltd you have chosen the right partner because –
We Care for your Money: We know Supplement manufacturers / brand owners don’t have billion dollar drug company R&D budgets. Every Euro / Rupee spent goes into creation of valuable data and not used in chasing mindless objectives. Our botanical research projects may be at no more than one-fifth the cost of similar size (sample size) drug trials.
We Understand your Research Objective: We understand the special needs of clinical research on botanicals. We are one of the few CROs who are involved in protocol and CRF design. Keeping in mind your marketing goals and drawing on our scientific expertise we jointly come up with the most suitable research plan for you.
We don’t Compromise Quality: All projects are conducted as per ICH GCP guidelines. Sponsor’s representative or third party auditors can audit projects at any time for checking quality of our documentation and data management.
We Respect your Time: Projects are conducted swiftly after approvals from Sponsor, local Regulatory agencies and Ethics Committees. Given all clearances and trial supplies from Sponsor, we offer high recruitment potentials of qualified subjects at multiple centers across the country and abroad for speedy conduct of trials.
We have strong systems: We have a strong but evolving quality management system compromising of detailed SOPs (Standard Operating Procedures), Records, etc. which have been audited by Sponsor appointed auditors and by ISO 9001:2000 certifying body Bureau Veritas Quality International (BVQI). This means standardization of our service and quality control of all projects undertaken under our supervision.
We have a respectable network of GCP aware Investigators: All our studies are conducted at experienced sites with either all or at least one site personnel fully aware and trained in ICH-GCP and having participated in such trials before. Several of our existing sites have been audited by Sponsor appointed-auditors from Europe.
We have access to well-equipped Central Laboratories: Most studies require biological samples to be processed at a Central facility to maintain high standards of data generated. We work closely with one or two Central labs in India, which have state of the art testing facilities and are fully geared for Clinical Research project management.
We have top of the line data management systems: Most of our clinical trial data management is outsourced with specialized data management outfits and biostatisticians equipped with Oracle Clinical and SAS / SPSS statistical package. We are in the process of acquiring our own Data management software and building a team for the same.
We have a Multi-Disciplinary Medical Writing Team: Clinical trial reports are built on scientifically weighted opinion of experts from the fields of modern medicine, herbal practitioners, statisticians, etc. This exposes the data to a variety of evaluation techniques and thought processes bringing out better the possible clinical applications of the investigational product.
Our work is published (so will be yours!): Several recently concluded studies are in the publication track right now in either conventional or online free access journals. Acceptance for publication in peer-reviewed journals speaks for the quality of our clinical trial protocols, conduct and medical writing.
We are a "Strategic Partner" rather than a contractor: We understand specific Nutraceutical Market needs and align complete research strategies to meet these market and regulatory needs.
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