Empowering sponsors with compliant data collection and integrity for a variety of clinical studies

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 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.

●       Cybersecurity 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™ 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 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 (eIC), 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 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.[1] 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.[2]

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 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.

Affordable subscription-based pricing of Jeeva makes it easier for the study teams to plan budgets with predictable expenses. The modular SaaS subscription model helps clinical researchers, Contract Research Organizations (CROs), and sponsors manage a clinical study’s annual budget on a simple, per participant basis.

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References

1.       https://www.sciencedirect.com/science/article/pii/S0165614719301300

2.       https://www.sciencedirect.com/science/article/pii/S0165614719301300#bbb0020

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