We listened to a couple thousand stakeholders of clinical research
Delays in patient recruitment and retention, ensuring diversity, equity, and inclusion, generating quality clinical evidence of safety and efficacy of treatments, tracking patients adherence to medication, and compliance with regulatory agencies such as Institutional Review Boards, FDA, EMA, GDPR, and other guidelines are critical factors.
Accelerate Patient Recruitment & Retention
85% of clinical trials are delayed due to the slow pace patient enrollment. 30% of clinical trials fail because they cannot meet their target enrollment. Every day delayed causes biopharmaceutical sponsors a loss of $600K to $8M. Patient recruitment involves identification of patients matching the inclusion & exclusion criteria for the specific clinical trial. Most patients screened do not match. Then, enrolling those small number of matching patients into the study. Only about 3% of matching patients are choosing to enroll in clinical trials. 1 out of 4 patients not enrolling cite logistical burden as the primary reason.
Maximize Diversity, Equity, and Inclusion
The randomized controlled clinical trials have been historically successful in enrolling Caucasian adult male participants from affluent backgrounds. Less than 10% of clinical trials include children. Women and minorities are less likely to participate in clinical trials as they have more logistical burdens and special needs such as childcare, transportation, and loss of pay.
Generate Reliable Clinical Evidence
Clinical research involves generation of high quality reliable clinical evidence of patient safety and outcomes. The traditional model of generating evidence during patients’ in-person visits to brick-and-mortar sites can no longer be solely relied on. Researchers and patients are questioning traditional models and seeking increased flexibility in the post-pandemic world.
Maximize Patient Adherence to Medication
Sponsors and regulators rely on the evidence generated by study volunteers’ use of Investigational new therapies as prescribed by their investigators in the approved clinical trial protocols. If patients miss medication routine or deviate from the protocol, that may deny the therapy its fair chance of demonstrating efficacy. Hence, ensuring that study participants adhere to clinical protocol is a critical factor.
Minimize Regulatory Risk and Maximize Compliance
Clinical trials are highly regulated at various levels including by institutional review boards (IRBs), human subjects protection guidelines, Good clinical practice (GCP) guidance by international code of harmonization (ICH) E6 R2, data protection guidelines guidelines such as GDPR, and other local or regional guidelines. The burden of ensuring regulatory compliance of technology solutions deployed in a clinical trial rests with the sponsors. Hence, adoption of newer innovative technologies introduces risks for sponsors.
Walk the Talk of Patient-Centricity
Patients are the center of clinical research. They are critical partners and not “subjects”. Yet, many clinical trials fail to incorporate patient voices early during clinical trial protocol development or logistical planning. Educating and informing patients about the goals of the trial and gathering their inputs are critical success factors.
Modular Software as a Service (SaaS) Subscription
Helps clinical researchers manage study budget on a simple per study participant subscription basis.
Automated Enrollment Workflows
Electronic Patient Reported Outcomes
2-way Email & SMS Communications
Upload Lab Reports
Adverse Event Reporting
Still curious if Jeeva eClinical Cloud is a good fit for your study?
Jeeva is designed to be disease-agnostic, device-agnostic, flexible, and modular to support patient preferred hybrid trial operations. Schedule a 30 minute call today to efficiently determine the fit. We will help you make an informed decision.