Vedic Lifesciences has an immense experience of efficiently handling Pharmaceutical, Cosmetic and Nutraceutical Clinical studys since 2000. We take the pain out of your clinical projects and assure credible data for your regulatory or marketing end goals.
The Study Feasibility Analysis and Site Selection are the basis of any successful clinical study. Our custom designed Questionnaires and processes effectively help the client to assess the costs, timelines, site capabilities, regulatory requirements and projected risks involved.
At Vedic Lifesciences, we understand the needs of our Clients and requirements of the study. Working on the complexities associated with the Study, our Project Managers take on the responsibility of planning and predicting uncertainties to reduce risks. Managing the resources effectively to adhere to stipulated time-lines, cost effectiveness and quality compliance.
At Vedic Lifesciences, our monitors ensure ICH-GCP compliance & data integrity at each site. The Clinical monitoring team ensures adherence to SOPs and promotes harmonious relationships with all our investigators and vendors. Our Monitors perform 100% Source Document Verification for Critical data and thus guarantee accurate and reliable data.
INVESTIGATIONAL PRODUCT MANAGEMENT
At Vedic Lifesciences, we offer our clients innovative and GMP compliant Packing, Labeling, Storage and transportation services to support product’s clinical study program.
Detailed database of Investigators across therapeutic areas like Cardiology, Orthopedics, Urology, Andrology, Endocrinology, Dermatology, etc. Vedic emphasizes on quality Investigator Relationship management and has exceled in maintaining this acssociation with all its investigators over long periods of time . The investigators are ICH-GCP trained and experienced in the conduct of Clinical studies.
We follow very strict quality standards as per ICH-GCP and Regulatory requirements to maintain Comprehensive Quality Control throughout a Clinical study. Our Quality Team periodically reviews SOPs, imparts training and ensures compliance by conducting regular in-house, site and vendor audits.
Vedic Lifesciences provides comprehensive Data Management Services which include processes from Database Design to Database lock.
We provide medical writing services for Study designs, Investigator Brochures, Protocols and other documents in accordance with ICH and applicable guidelines. We understand the need for fully integrated clinical study reports fulfilling all global regulatory & ICH-E3 requirements. Our in-house team has excelled at manuscripts which have been published in peer reviewed journals.
BIOSTATISTICSVedic Lifescienes uses validated statistical softwares for Randomization, sample size calculations, Statistical Analysis Plans, Planning and implementation of interim analysis, Final statistical analysis, writing staistical reports.