Jeeva Informatics Solutions

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CROs can partner with Jeeva to differentiate their services | Jeeva Informatics Solutions

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Human-Centric eClinical Trial Platform | Jeeva Trials

Traditional clinical guidelines, and stand-alone patient study and care pathways are proven to be increasingly inadequate, especially in a post-pandemic world with low clinical adherence, disrupted workflows, and stay-at-home orders. Disrupted workflows means more time required to complete a study, fatigue of the research team, and wastage of resources.

Researchers and study teams are increasingly adopting eClinical cloud trial tools that are designed to augment researchers, study teams and clinicians to augment their complex decision-making processes with targeted clinical knowledge, patient information and computerized clinical workflows. It directly improves the quality of clinical documentation. AI technologies provide the tool capabilities for drawing insights into data beyond what humans can. CROs (Contract Research Organizations) evaluate clinical study tools largely based on speed, flexibility and cost-efficiency. However, amidst these concerns, data integrity is not to be understated or taken for granted. Data integrity is not only important for a study, it needs to be addressed throughout the product life cycle across Good Clinical Practices (GCP), Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), and other Good Practice (GxP) areas.

Data integrity is critical for studies

Good risk mitigation and management is essential to data integrity as multiple points of risk exist throughout data recording, storage, transfer, reporting and other stages of data lifecycle during a study trial. It is achieved by making data traceable throughout audit trails. Transparency is demonstrated with a chain of custody from data origin to its analysis. Without data integrity, it is not possible to regenerate a previous clinical trial result reliably. Data integrity cannot be validated by point-to-point interfaces of individual systems alone, it requires a more holistic approach towards validation and quality management as these systems need to work together across corporate borders and multi-site systems.

Quality of data can affect the quality of decision support because if data collection is not standardized, the study trial data is effectively corrupted and increases the risk of failure during the submission procedure for approval by Food and Drug Administration (FDA), Medicines and Healthcare Products Regulatory Agency (MHRA) and other regulators. Regulators in the US and across the world continue to stress the criticality of data integrity in clinical trials.

Points to consider while choosing an eClinical study solution:

A good system should not delete or obscure previously-recorded audit trail information and prevent modification by the user.

It should record complete audit trail records including identification of the data element that was changed, who authorized the change and implemented them.

It should provide early visibility to reliable data to quickly make sound decisions and bring life-enhancing treatments to life.

Cyber security is a mission-critical consideration for electronic clinical outcomes assessment (eCOA) risk management for any eClinical solution.

Regulatory-minded study teams will have data integrity plans in place as regulators can raise questions about data collection compliance, warranting rescue action. By utilizing the Jeeva Informatics eClinical cloud, study teams can have regulation-compliant risk mitigation with complete transparency, traceability, and documentation. Jeeva is a flexible bring your own device (BYOD), SaaS (Software as a Service) solution that is designed to maintain data integrity with features and protocols that fit the specific trial protocol, ensuring reliability and authenticity of the study data by adhering to the most current compliance regulations in force.

Shortening the Distance from Study Data to Action

Jeeva’s highly scalable SaaS architecture provides a cost-effective approach to support trials for multiple studies, phases and therapeutic areas. Its intuitive interface eliminates the multi-step process to navigate reports and shortens the distance from study data to action. In clinical research, data integrity and reliability of trial results are paramount. The value of a comprehensive and compliant eClinical tool is absolute. Data integrity continues to be a major theme across inspection results. The collaborative technology used in Jeeva automates high-value clinical trials recruitment and retention tasks and provides insightful retrieval of information. Adherence to the International Council on Harmonization (ICH) GCP is a core tenet for data integrity at Jeeva.

Leading research organizations have consistently been using Jeeva for compliant and adaptive research with access to immediately actionable patient data. It provides researchers personalized clinical study documentation across solutions, platforms and devices, anytime and anywhere, regardless of physical location.

Enabling Clinical Research at Scale

A failed trial not only sinks investment into the early stages of the trial itself but also results in dissatisfied sponsor clients and impacts your long and fruitful business relationship with them. Jeeva is designed to support the conduct of clinical trials utilizing validated functionality and processes. The modular software enables clinical research at scale and saves more than 70% time and logistic burden on the study teams. Utilizing the platform-agnostic software with advanced features like bi-directional communications, scheduling and touch-less electronic informed consent, investigators can rapidly enroll participants in the study, and investigators can safely review the study material remotely and conveniently from their own mobile device.

Complying with the Current Regulations

Jeeva Trials follows a human-centric approach with a deep understanding of the perspectives and requirements of various stakeholders including regulatory compliance specialists, IT security and privacy professionals, auditors and coordinators. The burden of ensuring regulatory compliance of technology solutions, GDPR (General Data Protection Regulation), Institutional Review Boards (IRBs), human subjects protection guidelines, GCP (Good Clinical Practice) guidelines by ICH (International Council of Harmonization) of Technical Requirements for Pharmaceuticals for Human use, and other regional guidelines lies with the study sponsor. Jeeva adheres to the current federal, state, and international regulations or guidelines for conducting clinical trials using electronic patient data such as the FDA 21 CFR (Code of Federal Regulations) Part 11, SOC 2 (System Organ Classes), Amazon Well (AWS) Architected Framework Review, AWS Foundational Technical Review, GDPR privacy policies, and others. Avoid having to validate multiple a la carte tools as you can now achieve the same goal with a single all-in-one integrated SaaS platform.

Saving on Costs of Failed Trials

It takes on average 10-15 years and USD 1.5-2.0 billion to bring a new drug to the market. Approximately half of this expenditure covers testing, preclinical compound discovery and regulatory processes. The high failure rate of clinical trials due to regulatory issues, patient non-adherence, low retention and high drop-offs during long-term studies is a major stumbling block in drug development. Less than one-third of all Phase II compounds advance to Phase III, with more than one third of all Phase III compounds failing to advance to approval. The most complex Phase III trials carry nearly 60% of the overall trial costs, resulting loss per failed clinical trial to the order of 0.8-1.4 billion USD.

Flexible Platform to Accelerate Patient Recruitment

Study build delays cause timelines to drag on, as such CROs face not only dissatisfied sponsor clients but they could lose a fruitful business relationship. There are major regulatory implications as well, as unverified, disintegrated and dubious data quality can land organizations in court. Jeeva Informatics Solutions is designed to reduce timelines for study startup and participants by up to more than 50%, while complying with data integrity regulations of the federal and state governments. Jeeva makes it easy for longitudinal cohort studies to collect validated data from participants in real-world settings over extended periods of time. The flexible platform accelerates patient recruitment and retention, and enables long-term engagement for 5, 10, or 15-year follow-up studies for long-term trials, such as cell and gene therapy.

Disparities related to diversity, equity, and inclusion (DEI) are common and well-known in clinical trials. It is well-documented that racial minorities, underprivileged, and non-white ethnic groups are much less represented in clinical trials. Historically, the numbers of clinical trial participants from diverse populations have not reflected real-world populations. Minorities often underrepresented in clinical trials include women, members of the LGBTQ+ community, indigenous populations, older adults, Native Americans, pediatric patients, and people living in hard-to-reach geographies.

In the United States, socio-economic and geographic divides persistently limit patient diversity in clinical trials. As a result, we have only partial understanding of how safe and effective therapies are when they launch. Without diverse communities, researchers run the risk of making assumptions about drug safety and effectiveness that may not be accurate. There is a need to increase participation and retention among diverse patients who may otherwise not be invited to participate in clinical trials for new drug development. Not only would these measures provide pivotal data for a variety of backgrounds, but it would also provide these study participants with first access to new precision therapies at no cost, a privilege of the few.

Why are inclusive clinical trials important?

Addressing the challenges of diversity, equity and inclusion in clinical trials is important because there are many occurrences when drugs behaved differently from one population to another. Failing to understand these differences at the clinical trial stage, in which patients are monitored most closely, could result in suboptimal drug efficacy and potentially avoidable safety issues due to overexposure and underexposure to the drugs in many future patients. Having representative patient populations in clinical trials helps ensure the safety and effectiveness of therapies for everyone.

How to increase diversity, equity and inclusion in clinical trials

Do not select a site merely because of familiarity or convenience, especially if these sites have no demonstrable reach in that community beyond their location. Clinical Trial sites should include locations with a higher concentration of racial and ethnic minority patients. Factor in relevant disease prevalence data in those areas when designing protocols or planning recruitment initiatives.

Do not treat Black and Brown communities as monolithic groups that have the same life experiences. Do not set people of color into shallow narratives and stereotypes, such as Black people can only be reached through the church. Similarly, defaulting to do business with majority-owned (read: White) firms simply because they are familiar, and you feel comfortable to communicate and connect with them is not the right practice.

It is important to carefully examine exclusion and inclusion criteria to ensure they are necessary to achieve study objectives and that they do not pose an unnecessary barrier for would-be enrollees. When possible, reducing the frequency of study visits, collaborative strategies, expanded access, flexibility in visit windows, and electronic communication tools should be employed to make trials more inclusive. Clinical trial participation should be made less burdensome for the volunteers and caregivers.

Legal frameworks and recent initiatives to improve diversity and inclusion in clinical trials

Improvements in DEI initiatives have of late come from recognition by drug developers, lawmakers, sponsors, patient advocates and regulatory authorities of the importance of DEI in clinical trials, and how sociocultural variables reverberate in clinical research. In reality, the void in diversity, equity and inclusion in clinical trials and research is an old problem as it only represents a disproportional disease burden. What is unprecedented is the widespread attention that diversity, equity and inclusion has gotten in clinical trials recently. The fierce urgency to develop effective coronavirus solutions means that these inequities in clinical trials are finally getting the attention long needed.

Indeed, there is a need to address the issues of diversity, equity, and inclusion in clinical trials if innovators are to fulfill their promise of precision medicines for each individual. Information flow, data sharing, and reducing the logistical burden to participate are high-priority areas to improve access for underrepresented populations. This is also true in research laboratories where the greater the diversity of the participating patient population, the higher the chances that certain breakthroughs from clinical trials may be achieved.

Overcoming barriers and achieving DEI in clinical trials with technology

Systematic change in how we approach the issue of diversity, equity and inclusion in clinical trials is needed for the real clinical trial diversity to transpire. The Jeeva eClinical Cloud (Jeeva) is a modular Software as a Service (SaaS) subscription model that is designed to help a clinical study’s annual budget on a simple per participant basis, while ensuring that the study participants are truly represented to include diversity, equity, and inclusion. The platform has many features such as eConsent, pre-screening, automated enrollment workflow, adverse event reporting and more to maximize diversity, equity, and inclusion for the participants, such as women and minorities that are less likely to participate in clinical trials due to logistical burdens and special needs such as childcare, transportation and loss of pay.

Walking the talk of patient-centricity

Jeeva considers patients as critical partners, not merely subjects of study, and walks the talk of patient-centricity. The cloud platform incorporates patient voices early during clinical trial protocol development and logistical planning. Jeeva believes that humanizing the workflows leaves room for humanizing the patient experience, and creates an atmosphere of trust, especially among the communities of color and ethnic minorities that have traditionally been underrepresented in studies. Jeeva is developed by researchers with empathy who listen to help clinical researchers, hospitals, academia, CROs and biopharmaceutical sponsors to address the issues of diversity, equity and inclusion in clinical trials, and accelerate patient recruitment by three times faster.

Minimizing regulatory risk and maximizing compliance

Jeeva’s bring your own device (BYOD) platform makes it easy for study investigators to onboard, retain and engage participants with an appropriate focus on diversity, equity, and inclusion. Jeeva’s experienced coordinators are trained to manage trial operations to minimize burden, reduce dropouts, and improve compliance meeting regulatory requirements at various levels, such as Good Clinical Practice (GCP) guideline by the international code of harmonization (ICH), human subjects’ protection guidelines, data protection guidelines such as GDPR, and institutional review boards (IRBs) that help in accelerating the development of therapies.

The platform is designed to enhance geographic and demographic diversity and reduces 70% burden on study teams and participants to collect data that are representative of the population. Jeeva supports multi-site studies with centralized monitoring dashboard, and centralized study management & monitoring.

CROs can differentiate their services to sponsors with the white-labeled Jeeva eClinical technology platform advantage

The COVID-19 pandemic brought a new sense of appreciation for clinical trials as masses watched clinical trials closely while pharmaceutical companies raced against the clock to find viable vaccines and drugs for the Coronavirus outbreak with accuracy and unprecedented speed.

But we also got a glimpse of how challenging clinical trial management can be for companies. This challenge brought a renewed sense of appreciation for human-centric software that streamlines the clinical trial process.

For biopharmaceutical and medical device sponsors, CROs, or sites, adopting a software-as-a-service (SaaS) also comes with the benefit of flexible pricing. For example, systems like Jeeva offer a modular trial-fit subscription model with pay-per-module-user pricing. This means the trial’s capital expense can be managed as a predictable operating expense.

The clinical trial cloud software market has grown as decentralized clinical trial management systems prove their worth as a silver lining of the pandemic. But how does SaaS accelerate clinical trials and make them more efficient?

1.       Forms and Process Management

Firstly, a clinical trial management system assists users to manage the paperwork and documentation necessary to get through the clinical trialing process. 35% of patients who dropped out of a study found the Informed Consent Form hard to understand, making it difficult to push through.

With the help of the right systems, patients get a better understanding of the whole process and trial administrators and concerned bodies can get feedback from prospective patients faster if there’s ever any part of the process that needs more clarity.

With integrated process management systems, clinical trials run smoothly and have a better road map for patients and administrators alike to ensure that the study runs through all operational stages with little friction.

2.       Patient Management

Patient recruitment is a major issue for sponsors during clinical testing of interventions. First, finding volunteers willing to take time out to contribute to research and development is a challenge. And then there’s creating a log of all their information, experiences, and results without allowing data to fall through the cracks.

Using a clinical trial management system, companies and test administering committees can better track patient data and get a future database of possible candidates for more trials. Patient management systems help avoid losing patient data, duplicating tests on one person, getting lost with controls and placebos, and other directory and test data management issues.

Additionally, implementing a modular BYOD (Bring Your Own Device) solution like Jeeva makes it accessible to users on any browser-enabled mobile device, accelerating patient enrollment and engagement. It also provides bidirectional communication between staff and patients through email, SMS, audio, and video calls. Offering remote eConsent also reduces friction as participants get thorough patient education and fully informed consent. This eliminates confusion and complexities from lengthy paper works.

3.       Data Management and Analysis

Medical data — like most data— became a new hot commodity in the healthcare industry. That’s why trends like medical coding training and big data in healthcare are on the rise. It’s hard to belittle the importance of data collection and management, especially in clinical trials where the data shows the results.

Many of today’s most common data management pitfalls have to do with trusting storing, collecting, and crunching data to a group of people who do things manually. Just as the computer took out the need to manually calculate trajectories and launch scenarios for NASA, data management and analysis tools can help speed up the data management process in clinical trials and give a more accurate result. Companies also provide all necessary clinical trial management system training to help study coordinators to automate many processes and help them save time and effort on administrative data-related tasks.

4.       Data Security

Along the lines of the data conversation, data security is also crucial. Fraud, identity theft, and phishing are only some cybercrimes that virtually didn’t exist two decades ago. As healthcare and pharma companies now shift towards using cloud software to empower clinical trials, data management systems help secure all patient data to avoid any leaks or hacks.

Clinical trial management software often comes with adequate layers of encryption and authentication to ensure that only authorized personnel can access data related to patients, their health, and the clinical trials themselves to ensure complete confidentiality where it’s absolutely needed.

5.       Compliance Monitoring

A great number of deadweight costs go into non-compliance with government and approving boards. Fees for non-compliance can go up to at least $12,000 a day, resulting in significant wasted resources on hiccups that you can improve by using a tool that offers compliance monitoring. Thankfully, clinical trial database systems mostly come with compliance monitoring capabilities that help administrators and researchers keep track of compliance requirements and their progress.

By automating compliance monitoring, research teams, CROs, partners, and the federal bodies involved— such as the FDA— receive regular updates on test progress and provide a centralized hub for all findings, publications, and other necessities to do tests the right way.

Automation in Healthcare

Evidence linking interventions with health outcomes is vital for healthcare decision-making. Making sound choices about healthcare requires the best possible and quality evidence from clinical research. However, some of the decisions currently made during the drug development process are not supported by high-quality evidence.  As such, making informed decisions for allocating adequate resources to guide clinical Research development becomes challenging. At mid-stage clinical development, the challenge entails in determining the specific indication, if there are multiple potential indications. Moreover, evidence that is complete for some individuals or groups may be incomplete for others, leading to inefficiencies in decision-making.

Evidence generation strategies are especially important at Phase III and Phase IV trials to allow for effective navigation through competitive and regulatory hurdles, while it may be difficult to effectively communicate potentially attractive product attributes to the stakeholders, especially when it has no clear advantage over comparators. Stakeholders also lack the evidence needed to make real-world decisions on approval, coverage and use of treatments as most current processes used in evidence generation focus narrowly on the safety and efficacy of treatment.

Datasets to inform real-time decision making

The traditional demarcation between pre- and post-approval phases does not fit many medical products, as regulatory decisions could be informed by the same evidence that informs the use and coverage decisions, though the criteria for decisions should not be the same for both cases. Validated tools, based on large datasets to help inform real-time decision making are invaluable, yet they are currently limited. When new treatments are approved, healthcare payers and those who participate in shared savings base coverage determination on their value which is calculated by the evidence of benefit and net costs. The incorporation of real-world data (RWD) and patient-reported outcomes (PRO) into the evidence generation process could assist in making coverage determinations by rendering clinical evidence and research more immediately translatable to the beneficiary population.

Real-world data (RWD) and real-world evidence (RWE)

Additionally, large differences usually exist between the evidence required for initial adopters, such as surveys and studies, and that required for most prospective randomized control trials (RCTs). While the healthcare community uses RWD and RWE to develop decision support tools for use in clinical practices, medical product developers use these data to support clinical trial designs and observational studies to generate innovative treatment approaches. FDA uses RWE and RWD to monitor adverse events, post-market safety of the drug, and to make regulatory decisions. While RWD can be collected from various sources such as electronic health records (EHRs) and product and disease registries, RWE can be generated by different study designs including observational studies and randomized trials.  

Aligning stakeholders for evidence generation

Aligning stakeholders is another big challenge of evidence generation as different stakeholders will have their own perspectives on uncertainties throughout the drug development lifecycle. Regulators may have different views as to what is acceptable to that of the patient. As such, it remains an industry-wide challenge to provide credible evidence for clinical research to innovators and investigators. Challenges exist for healthcare innovators to keep up to date with compliance and regulations about evidence generation as regulatory space evolves fast.

Because pharmaceutical companies tend to delegate evidence generation to individual departments that are often siloes, the process occurs sequentially, resulting in delays in crucial milestones such as getting regulatory approval before initiating an outcomes-based study.

https://www.futuremedicine.com/doi/10.2217/cer-2017-0073

An analytical framework model that makes clinical sense

There is a pressing need for high-quality evidence generation as regulators and payers seek more long-term data on product safety and effectiveness. As such, more efficient methodologies for generating evidence are required for decision-making, and to enhance clinical evidence collection and interpretation. An analytical framework model makes clinical sense as an evidentiary pathway, however, the challenge for investigators in evidence gathering is to fill out the framework. If the study design is weak, then the link in the evidence chain is also weak. Studies need to be carefully and prospectively designed, and opportunities exist to add well-designed studies into current practices. Study teams and researchers should consider how to most effectively translate diagnostic tests into practice needs within clinical settings.

Quality clinical evidence of safety and efficacy

The Jeeva™ eClinical Cloud platform provides clinical decision-makers with a modular and integrated approach to evidence planning and generation. From a single dashboard, study leaders can monitor data in real time to track safety and efficacy in representative patient populations across vast distances. The Jeeva™ eClinical Cloud is designed for efficient, remote long-term follow-up, natural history and other observational studies as well as interventional clinical trials regardless of therapeutic area. Jeeva™ enables quality clinical evidence generation to evaluate treatment safety and efficacy and tracks patients’ adherence to medications, in compliance with regulatory agencies such as Institutional Review Boards, EMA, FDA, and GDPR.

Digital-first approach to evidence generation

Study teams, innovators, drug developers, biopharmaceutical sponsors, clinical researchers, hospital sites and contract research organizations (CROs) face challenges to overcome the “no evidence, no implementation—no implementation, no evidence” paradox. Jeeva™ provides a new, digital-first, patient-centric approach to evidence generation that considers patients as partners for clinical trials, not merely subjects.  

The Jeeva™ eClinical Cloud is user-designed software-as-a-service (SaaS) platform that allows volunteers to conveniently complete clinical trials wherever they are. The flexible and modular bring-your-own-device (BYOD) solution works on any browser-enabled mobile device and cuts out 70% of logistical burdens for study teams and patients. The modular and flexible Software as a Service (SaaS) subscription-based model is enriched with many features such as automated enrollment workflows, electronic patient-reported outcomes, 2-way email and SMS communication, uploading of lab reports, and more that are designed to encourage innovators to undertake research activities, rather than be intimidated by the complexity, logistical burdens, duration and costs of the traditional evidence generation approaches.

Quickly setup clinical studies of any scale or duration