iVRS

iVRS News

Successfully Completed 100 + Extractable and Leachable (E & L) Studies.

Extractable & Leachable Studies conducted at iVRS has been approved by USFDA and Health Canada.

In Vitro Release Test (IVRT) Studies conducted at iVRS has been accepted by Saudi Food and Drug Authority (SFDA).

Successfully completed PK based bioequivalence study of Cladribine in RRMS Patients for Jordan Food and Drug Administration (JFDA) submission.

Rich Experience in Handling Global Biosimilar Studies.

Successfully Completed Global Ophthalmology Device Study.

Our Process and Systems are ISO 9001 & ISO 27001 Compliant.

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Clinical Sevices - Clinical Monitoring

Clinical Monitoring

iVRS offers comprehensive clinical trial monitoring services from feasibility to site closeout to support clinical trials across the globe. All monitoring activities are conducted in accordance with the study protocol, clinical monitoring plan, standard operating procedures, ICH GCP, and applicable regulatory requirements.

We have dedicated ICH-GCP trained Clinical Research Associates (CRAs). Our CRAs ensure monitoring at the chosen sites and our monitoring team work to manage and develop productive relationships with the sites through strong communication, organizational skills and regulatory compliance.

Our clinical trial monitoring is provided by qualified, knowledgeable
professionals with extensive clinical research and therapeutic area
experience.

Each monitor at iVRS has a rich monitoring experience who can develop and manage highly functional sites across India. Our clinical monitoring services included the following:

◘ Site identification

◘ Site feasibility assessments

◘ Site qualification & initiation inclusive of exclusive trainings to site team during SIVs

◘ Comprehensive study specific monitoring plans

◘ Site monitoring & management inclusive of co-monitoring, remote monitoring and risk-based monitoring- Thorough review of site records, timely completion of visit reports, quality review of monitor reports, source document verification as per monitoring plans, rapid query resolution

◘ IP management

◘ Site Closeout

Let us talk

If you are an organization looking to engage a diligent, effective and reputed clinical research organiztion, you’ve come to the right place. In Vitro Research Solutions was set up to help organizations like your’s achieve integrity,
speed and efficiency in your research requirements.

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Address

Bangalore, India

Call Us

+91 80 45500700

Email Us

info@ivrs.org.in