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Human Studies

Vedic Lifesciences has immense expertise in efficiently handling claim substantiation studies in healthy volunteers or clinical subjects for Nutraceutical, Herbal, Pharmaceutical and Cosmetic products. We take the pain out of your clinical projects and assure credible data for your regulatory or marketing end goals. Our multi-functional team is trained to ensure maximum efficiency in taking your concept from claim to fame!

Benefits to the client:

  • Careful alignment of our Research Strategy with Client’s Marketing and Regulatory Strategy
  • Regulatory compliant claim statements
  • Quick study start up
  • Precise study documentsfor greater regulatory acceptability
  • Complianceto ICH-GCP and other applicable regulations to minimize risk of rejections by Agenices
  • Faster IRB approval rates
  • Faster Recruitment and higher retention rates
  • Transparent and accurate pass through costs
  • Cost savings up to 30-40%
  • Real time access to project status reports and study data
  • Credible and accurate Clinical Study Reports acceptable to global regulatory bodies and scientific journals
  • Early acceptance byhigh impact factor peer reviewed journals
  • Higher chances for approvals or favorable review by FTC, EFSA, Health Canada and other agencies

STUDY PLANNING

A study well planned is a study half done. Our clients come to us for specific marketing and regulatory outcomes. Through numerous discussions with the client teams, we ensure good alignment of the study objectives with the expected goals for the product being developed. With study objectives clear and agreed, the Vedic Clinical team proceeds to do a study feasiblility

STUDY FEASIBILITY

The Study Feasibility Analysis and Site Selection are the basis of any successful clinical study. Our custom designed questionnaires, checklists and processes ensure that all the parameters for the study are assessed and evaluated. A detailed feasibility effectively helps the client to assess the costs, timelines, site capabilities, regulatory requirements and projected risks involved. Normally a study cost proposal is made after such a feasibility but tentative costs and timelines may be available on request in some cases without the formal feasibility.

PROJECT MANAGEMENT

Human studies are complex research projects involving several participants sometimes across continents and disciplines. A poorly planned or ill-managed human study project can only lead to disappointments. At Vedic Lifesciences, we understand the needs of our clients and requirements of the study. Each project is assigned a dedicated and trained Project Manager, who serves as a one point contact for the client, updating them on the status 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, a dedicated and trained team ensures better coordination in multicentre studies. Human studies at Vedic are conceived and managed to ensure minimal costs and time incurred on unnecessary data collection including lab tests yet keep risk of study rejection in mind always. This is a fine balance between costs and risks of failure which only a team such as ours can master with our decade and more of experience serving the industry.

CLINICAL MONITORING

Clinical Study Principal Investigators (PIs) are busy folks. It is impossible for busy clinicians such as these to manage their routine hospital responsibilities and at the same time ensure all data is complete as per the guidelines and the study protocol. At Vedic Lifesciences, our monitors ensure ICH-GCP compliance & data integrity at each site. The Clinical monitoring team, having an average experience of 4-6 years, ensures adherence to SOPs and promotes harmonious relationships with all our investigators and vendors. Our Monitors perform 100% Source data Verification and thus guarantee accurate and reliable data. Protocol deviation logs maintained and reviewed regularly, Monitoring Visit Follow up letters sent to the site within 7 working days of monitoring visit, regular communication with the sites and frequent internal team meetings and discussions to ensure compliance. We maintain rigorous levels of study monitoring till the end of all our human studies ensuring highly credible study data, making us probably the only Clinical Research Center of its kind in the Nutraceutical World.

TEST PRODUCT MANAGEMENT

At Vedic Lifesciences, we advise our clients on complete management services for their test product from import to use in clinical study and return after study. We offer innovative and GMP compliant packaging, labeling, storage and transportation services to support product’s clinical study program. The test product dosing, dispensing, retrievals are monitored continuously to ensure compliance to the study protocol.

QUALITY ASSURANCE

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.

DATA MANAGEMENT

An otherwise well-managed study can go to dust if the data capture and data management that finally emerges from the study center is faulty. Vedic Lifesciences projects involve comprehensive Data Management Services which include processes from Database Design to Database lock. At Vedic we use internationally acceptable tools for data collection but constantly innovating to minimize time and cost for this critical operation in the human study.

MEDICAL WRITING / DOSSIER PREPARATION

Drafting and finalization of a scientific document or dossier ensuring quick permissions for a research study or marketing approval or any other submission to the authorities is a rare skill. Known as Medical / Technical Writing or Dossier preparation this requires presenting the facts of the matter in a clear and concise manner giving a scientifically compelling reason for the reviewer to grant their approval.

We provide medical writing services for Study designs, Investigator Brochures, Protocols and other documents in accordance with ICH and applicable guidelines. All the study documents are prepared in consultation with the client, medical experts, statisticians and clinical operations maintaining high standards of scientific and professional integrity ensuring favorable review by the authorities including regulatory agencies (FDA, EFSA, etc.), IRBs, patent offices and journal editorial boards.Wealso conduct comprehensive literature review and literature search for compiling regulatory dossiers and gap analysis reports.

Our in-house team has excelled at manuscripts which have been published in international peer reviewed journals.

BIOSTATISTICS

Vedic Lifesciences uses validated statistical software for randomization, sample size calculations, developing statistical analysis plans, planning and implementation of interim analysis, final statistical analysis, writing statistical reports. The data analysis is done as per the Statistical Analysis Plan and data presented as per the required formats.