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The global clinical data analytics market will be worth $13.8 billion by 2023 according to a ResearchAndMarkets report. It identifies the growing popularity of EMR’s as the key driver of this growth. However the clinical development industry is still grappling with problem of disintegrated and non-standardized critical trial processes which is further handicapped by its nature of data heterogeneity in the market.
The costs of clinical trial operations are continuously being evaluated for ways of achieving greater efficiency while reducing expenses. Many biopharma companies, now more than ever, focus on containing costs while maintaining quality. This approach applies to eClinical technology used to support a trial. An eClinical solution should include best-in-class integrated technology that is cost-effective, high quality, and efficient.
An example of this type of technology used in clinical research is electronic data capture (EDC) combined with interactive response technologies (IRTs) such as IVR (integrated voice response). This software combination has proven effective in reducing the cost of clinical trials. These integrated solutions will increase the efficiency of a clinical trial and provide a single environment with the flexibility and scalability to keep pace with demands.
Most of the integrated eClinical solutions are the result of single technology solutions that are paired together or integrated into a suite of eClinical solutions, resulting in a single platform with multiple components such as EDC and IVR. Comprehensive multicomponent solutions that contain EDC/IVR/CTMS (clinical trial management system) labs built from the ground up as a single integrated solution are uncommon and rarely best-in-class.
The emergence of integrated solutions results from the need to gain access to central lab data, EDC, and IVR data, including ePRO within a single system in the fastest, most reliable manner. As integration solutions have evolved, the continuous challenge is to improve the level of data integration beyond a transfer or sharing of flat files to true integration.
Integrated approach makes business sense
A platform that integrates data sources in real time benefits the end user by providing immediate access to various forms of clinical data including central lab, IVR, and EDC data. Such visibility across different sources can bring immediate attention to data quality and patient safety issues. This in-turn will reduce errors, mitigate risk, reconcile data and minimize redundancy.
An integrated platform based approach causes a ripple effect which starts with making standardized data available for single study as well as aggregated across studies in a single repository. In effect, the end user no longer need to log in to multiple systems. This single source of truth reduces data redundancy, increases data traceability across technologies and improves the quality and reliability of shared data between applications. The centrally held data can now be efficiently used for reporting, insight generation with analytics leading to faster decision making. Thus, it makes a lot of business sense for the sponsor or the CRO to select a vendor that provides an integrated platform based solution.
Traditionally, clinical projects are executed in siloed manner; with redundancy, delay, inflation and ambiguity that emerge as byproducts, more than the valuable insights. The siloed approach in the clinical context is viewed as a socio-technology problem. It needs the cooperation of both realms and this itself indicates the need to integrate clinical data processes. An end-to-end integrated approach would resolve the complexities that rise out of silos.
In this context McKinsey and Co articulate the need of an integrated approach very aptly as, “Effective end-to-end data integration establishes an authoritative source for all pieces of information and accurately links disparate data regardless of the source—be it internal or external, proprietary or publicly available.”
Implementing an end-to-end integration requires certain capabilities: inclusion of trusted sources of data and documents, the ability to establish cross-linkages between elements, robust quality assurance, workflow management, and role-based access to ensure restricted visibility of specific data elements.
Flexibility – How innovative, and right-size company like MaxisIT can be more flexible and agile?
Unable to take up smaller slices of a large project, large companies increase the cost of the project compelling the sponsor or CRO to depend completely on the one vendor. However, with an integrated platform approach, MaxisIT can reduce the costs by rendering technology solutions to specific, standalone problems.
MaxisIT as an Integrated Clinical Development Platform strives to embrace a problem-solving approach rather than a scale-congenial approach. Our process allows us to solve clinical data and development problems using an integrated approach in a flexible and agile manner.
Most importantly, we have been able to demonstrate that our solution is compliant with regulatory guidelines and can be configured to the type of study or data management needs. The highly frustrating problem of cohesion between compliance and data format is fully taken care by our solution.
We see that though large software companies have bigger bucks for visibility, they don’t have enough bandwidth to pay attention to small challenges that arise during implementation. MaxisIT along with its customer support attends to the smaller details too while delivering the integrated solution.
Why MaxisIT for an integrated solution?
At MaxisIT, every clinical data management project matter to us. We see to that each process of a project revolves around one common mission—to strive for healthier and better life. To make this happen, we try harder and focus on integrating different processes across the lifespan of a drug development process, rather than worrying about the size of the project.
We clearly understand strategic priorities within clinical R&D, and we can resonate that well with our similar experiences of implementing solutions for improving Clinical Development Portfolio via an integrated platform-based approach; which delivers timely access to study specific as well as standardized and aggregated clinical data, allows efficient data quality management, clinical reviews, and statistical computing.
Moreover, it provides capabilities for planned vs. actual trending, optimization, as well as for fraud detection and risk-based monitoring. MaxisIT’s Integrated Technology Platform is purpose-built solution, which helps Pharmaceutical & Life sciences industry by “Empowering Business Stakeholders with Integrated Computing, and Self-service Analytics in the strategically externalized enterprise environment with major focus on the core clinical operations data as well as clinical information assets; which allows improved control over externalized, CROs and partners driven, clinical ecosystem; and enable in-time decision support, continuous monitoring over regulatory compliance, and greater operational efficiency at a measurable rate.
14 Jul 2016