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 - Investigator & Site Selection

Investigator & Site Selection

We can quickly identify potential sites/investigators both from within and outside our network to cater to your needs. Our project management team has extensive contact with a majority of Investigators in India and other geographies and help in identification of potential investigators.

We follow standardized procedures to prequalify potential investigators. By prequalifying investigators and matching their skills to the specific needs of a study, we can assure that studies are staffed by well qualified and high calibre investigators. 

The selection of Principal Investigators is done based on the following:

◘ ICH-GCP compliant

◘ Therapeutic expertise

◘ Hospital infrastructure

◘ Ability to recruit patients

◘ Trial Experience of similar nature

Patient Recruitment Strategies

We understand the needs, challenges and dynamics of effective patient recruitment.

Our project management team and CRAs consider the impact of the following factors to blend an effective patient recruitment strategy:

◘ Protocol requirements

◘ Competing studies

◘ Locations of the trial

◘ Ethnic distribution of population

◘ Patient demographics

◘ Seasonal variations

Our patient recruitment experience encompasses a wide range of therapeutic categories, including Oncology, Psychiatry, CNS, Cardiovascular, Respiratory, Gastrointestinal, Metabolic, Dermatology and Women’s Health. We always reach or exceed our enrollment targets. Our highly trained research professionals use study specific screening questionnaire to obtain fast turn-arounds

We understand your need for fully integrated clinical study reports, incorporating all investigator and sponsor requirements, while still adhering to regulatory requirements. Our medical writers have considerable experience in writing these documents and presenting your data effectively and on time.

Our in-house medical writers are involved in the study through every stage to ensure a comprehensive understanding of the study – consequently our protocols and clinical study reports are insightful and accurate. Delivery of your final, summarized data will be presented in paper copy as well as password-protected electronic files. At the end of the study, we can also provide a full report containing all information ready for submission.

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