Solutions

Racial and Ethnic Diversity Plan (REDP) for Clinical Trials to Sponsors Submitting IND/INDA to FDA

Racial and Ethnic Diversity Plans for Biopharmaceutical Companies

FDA has now required biopharmaceutical companies to include a racial and ethnic diversity plan (REDP) in their IND submissions. The FDA has issued guidance to the industry on what is expected in this plan for ensuring all racial and ethnic populations are proportionally represented in their clinical trials across all phases based on the prevalence of the disease under investigation. 

Jeeva offers the development and delivery of REDP as a “fee for service” to support our sponsors. 

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Check our latest Conference on DEIA in Clinical Trials

Driving Global Diversity, Equity, Inclusion, and Access in Clinical Trials: Jeeva’s Vision and Insights Shared at Outsourcing Conference

As an invited speaker, Jeeva founder and CEO outlined his vision for helping sponsors, CROs, and Sites achieve global diversity, equity, inclusion, and access at the outsourcing clinical trials conference in Valley Forge, PA, in May 2023. Dr. Rajasimha also participated in a panel discussion moderated by the rare disease diversity coalition. 

Click here to download the presentation “What does it take to truly achieve DEIA in clinical” 

Advantages for IITs or ISTs

01
Study Design and Protocol Writing Assistance

With our chief medical officer leading the way, Jeeva’s team assists you with study design and protocol writing. We offer expert guidance and support to ensure a robust and well-structured study.

04
Data Support and Analysis

Jeeva’s trials team, led by Dr. Harsha Rajasimha, provides the biostatistical and data informatics support necessary during planning and downstream data analysis.

02
Seamless eClinical Solution

Jeeva's eClinical solution, managed by a dedicated team, facilitates quick protocol and eCRF configuration, patient screening and enrollment, engagement, EDC, and monitoring, using a variety of communication channels.

05
Overcoming Funding Challenges

We understand the unique challenges of IITs and ISTs, including limited funding, academic sponsors, government grants, or charitable donations. Sometimes industry may grant the intervention at no cost to support the study.

03
Enhanced Study Configuration Solution

If the protocol utilizes remote patient informed consent, TeleVisits, eCOA, or other decentralized tools, our team easily “adds” these features to the study configuration under the same login.

06
Supporting Other Studies

Additional studies that can be categorized under this model are observational, patient-funded studies, academic medical center research, patient foundation studies, non-profit organizations conducting approved clinical research, patient registries, natural history studies, and other cohort studies aiming for scientific publication.

01
Study Design and Protocol Writing Assistance

With our chief medical officer leading the way, Jeeva’s team assists you with study design and protocol writing. We offer expert guidance and support to ensure a robust and well-structured study.

02
Seamless eClinical Solution

Jeeva's eClinical solution, managed by a dedicated team, facilitates quick protocol and eCRF configuration, patient screening and enrollment, engagement, EDC, and monitoring, using a variety of communication channels.

03
Enhanced Study Configuration Solution

If the protocol utilizes remote patient informed consent, TeleVisits, eCOA, or other decentralized tools, our team easily “adds” these features to the study configuration under the same login.

04
Data Support and Analysis

Jeeva’s trials team, led by Dr. Harsha Rajasimha, provides the biostatistical and data informatics support necessary during planning and downstream data analysis.

05
Overcoming Funding Challenges

We understand the unique challenges of IITs and ISTs, including limited funding, academic sponsors, government grants, or charitable donations. Sometimes industry may grant the intervention at no cost to support the study.

06
Supporting Other Studies

Additional studies that can be categorized under this model are observational, patient-funded studies, academic medical center research, patient foundation studies, non-profit organizations conducting approved clinical research, patient registries, natural history studies, and other cohort studies aiming for scientific publication.

01
Study Design and Protocol Writing Assistance

With our chief medical officer leading the way, Jeeva’s team assists you with study design and protocol writing. We offer expert guidance and support to ensure a robust and well-structured study.

03
Enhanced Study Configuration Solution

If the protocol utilizes remote patient informed consent, TeleVisits, eCOA, or other decentralized tools, our team easily “adds” these features to the study configuration under the same login.

05
Overcoming Funding Challenges

We understand the unique challenges of IITs and ISTs, including limited funding, academic sponsors, government grants, or charitable donations. Sometimes industry may grant the intervention at no cost to support the study.

02
Seamless eClinical Solution

Jeeva's eClinical solution, managed by a dedicated team, facilitates quick protocol and eCRF configuration, patient screening and enrollment, engagement, EDC, and monitoring, using a variety of communication channels.

04
Data Support and Analysis

Jeeva’s trials team, led by Dr. Harsha Rajasimha, provides the biostatistical and data informatics support necessary during planning and downstream data analysis.

06
Supporting Other Studies

Additional studies that can be categorized under this model are observational, patient-funded studies, academic medical center research, patient foundation studies, non-profit organizations conducting approved clinical research, patient registries, natural history studies, and other cohort studies aiming for scientific publication.

Features of Jeeva

  • Works on BYOD Approach (Bring Your Own Device)

  • Ease of Data Analysis

  • Customizable and Configurable

  • Accessible from Various Hardware Devices of Varying Screen Sizes.

  • Time Saving

  • Secure Data Storage

  • Video/Tele/SMS/Email Communications.

  • Offers Remote Patient Monitoring, Assessments, and Follow-Ups.

  • Real-Time Live Interactive Communication Options.

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Compliance Programs Supported

Testimonials

Client Testimonials

  • In looking for a software partner, our research coordinators and investigators in the field could call the Jeeva team anytime, get reliable support, and have reassurance as we enroll patients on the go. You can count on Jeeva when time is of the essence in operationalizing a clinical trial.

    Dr. Emmanuel Gorospe

    Chief Medical Officer of KCRS

  • Jeeva is a game-changer for our rare diseases site/CRO. It is unfair to expect patients or healthy volunteers to visit a hospital or clinic when it is not necessary when a task can be effectively completed safely, remotely, and from the comfort of where they live.

    Marshall Summar, MD, Ph.D

    CEO, Uncommon Cures LLC

  • We are pleased to collaborate with Jeeva for the eCOA module for our investigator initiated observational study to understand toileting use by individuals with certain brain disorders

    Dr. Terry Jo Bichell

    CombinedBrain

  • Jeeva platform & service is aligned with our vision to making CAR-T cell therapies affordable in emerging markets.

    Rahul Purwar

    Founder at ImmunoACT

  • Jeeva gave us exactly the configurations we needed for our Pivotal clinical trials. I appreciate the functionality of the system.

    Mihaela Plesa, BA, CCRP

    Director, Clinical Research Programs at Frantz Viral Therapeutics

In looking for a software partner, our research coordinators and investigators in the field could call the Jeeva team anytime, get reliable support, and have reassurance as we enroll patients on the go. You can count on Jeeva when time is of the essence in operationalizing a clinical trial.

Dr. Emmanuel Gorospe

Chief Medical Officer of KCRS

Jeeva is a game-changer for our rare diseases site/CRO. It is unfair to expect patients or healthy volunteers to visit a hospital or clinic when it is not necessary when a task can be effectively completed safely, remotely, and from the comfort of where they live.

Marshall Summar, MD, Ph.D

CEO, Uncommon Cures LLC

We are pleased to collaborate with Jeeva for the eCOA module for our investigator initiated observational study to understand toileting use by individuals with certain brain disorders

Dr. Terry Jo Bichell

CombinedBrain

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Start Your Next Clinical Trial on Jeeva’s Unified Platform

See how Jeeva helps sponsors, CROs, and research teams simplify clinical operations and accelerate trial execution.

Office

10432 Balls Ford Road Suite 300 Manassas, VA 20109

Subscribe to the newsletter

Business woman operating a laptop
Sales rep smiling
Man wearing a blue shirt

Start Your Next Clinical Trial on Jeeva’s Unified Platform

See how Jeeva helps sponsors, CROs, and research teams simplify clinical operations and accelerate trial execution.

Office

10432 Balls Ford Road Suite 300 Manassas, VA 20109

Subscribe to the newsletter

Business woman operating a laptop
Sales rep smiling
Man wearing a blue shirt

Start Your Next Clinical Trial on Jeeva’s Unified Platform

See how Jeeva helps sponsors, CROs, and research teams simplify clinical operations and accelerate trial execution.

Office

10432 Balls Ford Road Suite 300 Manassas, VA 20109

Subscribe to the newsletter