We listened to over three thousand stakeholders of clinical trials
Delays in patient recruitment and retention, ensuring diversity, equity, and inclusion, generating quality clinical evidence of safety and efficacy of investigational medicinal products, tracking patients’ adherence to medication, and compliance with regulatory agencies such as Institutional Review Boards, FDA, EMA, GDPR, and other guidelines are critical factors keeping clinical trial operators up all night.
85% of Clinical Trials are Delayed by Over 30 days in Patient Recruitment
30% of clinical trials are terminated because they cannot meet their target enrollment in a timely manner. Every day delayed causes biopharmaceutical sponsors a loss of $600K to $8M in potential lost revenue from their investigational medicinal product. Patient recruitment involves the identification of patients matching the inclusion & exclusion criteria for the specific trial protocol. Most patients screened do not match, limiting the enrollment of those small numbers of matching patients. 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. Jeeva eClinical Cloud addressed this problem with automated workflows for screening and enrollment.
Sponsors are Seeking Strategies to Maximize Diversity, Equity, Inclusion, and Access
Randomized controlled clinical trials have been historically successful in enrolling Caucasian adult male participants from affluent backgrounds. Less than 10% of trials include children. Women and minorities are less likely to participate in trials as they have more logistical burdens and special needs such as childcare, transportation, and loss of pay. By adopting the Jeeva platform, Sponsors can empower investigator sites with the right tools and workflows for achieving DEIA goals.
ClinOps Teams are Concerned About the Validity of Clinical Evidence Generated in Clinical Trials
Clinical trials involve the generation of high-quality clinical evidence of patient safety and outcomes consistently across multiple investigator sites for accelerated regulatory reviews and ultimately, approval. The pandemic has challenged the traditional model of relying solely on patients visiting in-person to a brick-and-mortar site at every time. The types of data and documents to be collected during a decentralized or hybrid trial include eConsent, ePRO, eCOA, EDC, DDC, TeleVisits, VideoVisits, Lab reports, adverse events, and concomitant medications. Centralizing these on a robust data management platform can enable collaboration among all stakeholders in one digital platform.
Verifying Patient Adherence to Medication on a Daily Basis is a Critical Requirement
Sponsors and regulators rely on the evidence generated by study participants’ use of the Investigational new therapies as prescribed by their investigators in the approved 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. With the Jeeva omnichannel communications package, investigator teams can verify adherence by bi-directional SMS, emails, or audio/video calling channels.
8 out of 10 Investigational Drugs Fail During Clinical Trials
We understand that clinical development is prone to a high risk of failure of investigational therapies through the ‘valley of death’. About 30% of candidate drugs fail at each trial Phase 1, 2, and 3. Late-stage trials can cause significant loss of time, money, and lost market opportunity. Clinical trials are highly regulated at various levels including by institutional review boards (IRBs), human subjects protection guidelines, Good clinical practice (GCP) guidance by the international code of harmonization (ICH) E6 R2, data protection guidelines such as GDPR, and other local or regional guidelines. The burden of ensuring regulatory compliance with technology solutions deployed in a clinical trial rests with the sponsors. The secure and compliant Jeeva eClinical platform helps sponsors minimize risk and burden of ensuring regulatory compliance.
Sponsors are Keen to Earn the Trust of Patients
Patients are and should be at the heart of clinical trials. Clinical trial participants are critical partners and do not wish to be treated as “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 input are critical success factors. With Jeeva, Sponsors can activate a patient portal with the click of a button to effectively engage and earn trust of patients.
Modular Software as a Service (SaaS) Subscription
Helps clinical researchers manage study budget on a simple per study participant subscription basis.
Automated Enrollment Workflow
Remote eConsent
Patient-Reported Outcomes (ePRO/vPRO)
Clinical Outcomes Assessments (eCOA/vCOA)
Video, Audio, SMS, & Email Communications
Telemedicine or Video-calling
Upload Lab Reports
Adverse Event Reporting
What our client say
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 decentralized or hybrid trial operations. Schedule a 30-minute call today to determine the fit. We will help you identify gaps in technology, or protocol complexity, to enable an informed decision.