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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Project Management

“The success of any project depends on lining up the right resources, in the right combination, at precisely the right time”. iVRS delivers the competencies, resources and systems essential to cover every aspect of the drug development process. Our dedicated scientists, clinicians, investigators, regulatory experts are committed to highest quality of ethical standards. We provide services that would challenge assumptions about traditional clinical trial design and management so that credible, clean clinical data is obtained within budget, on time, every time.

Throughout the duration of the trial, iVRS offers the singular focus of a dedicated team for consistent effective interaction with study sites. The project manager, fully supported by iVRS, is responsible for seamless communications with your organization. Rigorous ongoing training for project teams in drug and disease management and compliance as well as protocolspecific practices assure you of a monitoring team with the clinical know-how to get quality results that meet timelines. 

We follow a rigorous scientific approach to the “art” of staffing, troubleshooting and risk management. Resource charts are prepared to facilitate the exact number of people in each speciality needed during each phase of the project. We develop critical path analysis that flags activities with dependencies. Based on past experience, we bring formidable analytical skills to minimize all possible risks. As your research partner through the critical phases, iVRS helps you develop strategies to:

◘ Recruit the right patients

◘ Conduct the study within estimated costs

◘ Ensure National, International quality and regulatory compliance

Clinical Sevices - Project Maagement

iVRS has well experienced global project management team to handle end to end clinical development processes. Our project management team comprises of experienced project managers who serve as the hub for key functions in the study, working to keep each project on time, on specification and on budget to meet your exact needs. Through a sound team structure, close communication, detailed tracking and metrics, our project management team delivers consistent high quality deliverables for our sponsors. iVRS provides comprehensive project management services by using different tools and techniques to execute simple to complex studies for regulated markets.

These delegated project managers are the primary point of contact for our sponsors who can provide customized and professional services that our sponsors can rely on, to lead the delivery of clinical trials. These delegated project managers are the primary point of contact for our sponsors who can provide customized and professional services that our sponsors can rely on, to lead the delivery of clinical trials.

Clinical supplies of the clinical studies are managed through a qualified service provider who has immense experience in managing packing, labelling, shipping of supplies to the sites.
Our project management offer the following:

◘ Project Planning and resource allocation

◘ Study specific trainings to the allocated resources

◘ Budget and site contract management

◘ Clinical supplies management

◘ Vendor Management including central laboratory services

Country expertise in feasibility

TMF setup & maintenance

Quality Control

Strategies and mitigation

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