Leveraging abundance of information available from internal and external sources, industry needs a transformational strategy by making a move from a retrospective modus operandi to a more predictable and proactive action oriented clinical research and development model; wherein key stakeholders can proactively plan and act in time rather than analyzing the outdated information on what happened in past.
Knowing the unknowns is important in an accurate and informed decision making, but in a timely manner with an optimal use of resources will help maintain integrity of decisions and balance the desired benefits.
Industry has either looked into this aspect or started to adopt manual solutions or has just realized the need of one unified solution.
Some of the evolving business scenarios are as centered either planning, operational or clinical activities but not one integrated. Operations performance indicators including but not limited to study start-up, enrollment, data acquisition rate, site close-out etc are largely variable on the competence of the executing CRO/s and provides primitive information based on hybrid approaches. Quality management and regulatory information management are equally vulnerable. Area that gets the most attention is the clinical performance indicators where there is maximum levy due to its key performance indicators being safety and efficacy. Industry is quickly transitioning from traditional conduct of clinical trials to more agile and adaptive designs. Learning the effects of study design early in the trial phases and identifying what works and what doesn't can save huge time and costs as well as allow sponsors to conduct trials with minimum patients using the dosage that will work. So there are enough motivations to pursue the adaptive designs but industry still remains at the stage of not having right infrastructure that can support such information management and decisioning process in an integrated fashion.
eAdaptive, an Integrated Clinical Portfolio Management solution shows a path forward in managing clinical business intelligence in a more informed and integrated manner; it allows managing portfolio of studies, monitoring execution of ongoing studies from both operational and clinical aspects, and tracking key performance indicators. eAdaptive caters to the needs of analyzing and reporting clinical study risks, opportunities and performance across the portfolio, so that key decisions can be made without any time delay.
Informed decisions-making is supported by role-based, intuitive, and secured web based environment that provides relevant information to the business users without compromising the validity and integrity of the studies. It utilizes various standard algorithms supporting forecasting and predictive analysis of key events within operational as well as clinical aspects of the portfolio; and helps visualize Critical Path Opportunities as well as potential risks early in the trial phases, and further allowing to take adaptive decisions to optimize design as well as resource planning.
Simply stated, this solution enables 360o review and analysis of a study or a group of studies from the top-down perspective, starting at the therapeutic area to a portfolio to study even at the site level. Cross-functional perspective and impact analysis allows making interim decisions with confidence. In case of adaptive research, it can address the need of monitoring planned adaptive design and optimize the key variables in due course. Utilizing CTRenaissance® integration services, it integrates with industry standard study design simulation tools and also with third-party algorithms.
Some of the key features within eAdaptive Clinical Portfolio Management solution are as under:
Portfolio Manager within eAdaptive provides various views such as resource manager, operations manager, quality manager, regulatory affairs manager, and clinical manager. Each view offers several pre-built standard analysis and tracking reports on key performance indicators. Each of them also offers ability to add more adhoc analysis as well as personalize the information digest.
Portfolio Manager also offers scenario planning capabilities to help management explore evolving trends and compare different combination of scenarios supporting the decisions that they would make. Scenario planning helps analyze potential interwoven effect of decisions across the functional areas by projecting the impact of the change.
Collaboration Manager within eAdaptive support role-based collaboration within and across the organizations by setting governance policies for each information that is being shared, reviewed, analyzed and collaborated. These programmatic firewalls further satisfies the regulatory concerns over compliance within such execution. Using this feature, sponsors can now setup collaboration among the key decision-makers such as data monitoring committee, statistical committee, sponsors non-study team and even quality & compliance oversight and collaborate on a common platform for efficient decision-making.
Below are some of the additional views and features:
- Role-based dashboard views
- Resource Management
- Trial Operations Management
- Site performance management
- Supply management
- Clinical Data review
- Study design monitor
- Biostatistical analysis
- Clinical safety and efficacy reports
- Portfolio Builder
- Scenario Planner
- Alert and notifications
- Cross-Functional Impact Analyzer
- Collaborative Framework
eAdaptive Clinical Portfolio Management:
- Allows clinical study strategy, planning and resource management
- Collaborates with internal and external stakeholders, efficiently and securely
- Monitors performance and establishes transparency across internal and outsourced processes
- Streamlines critical processes within adaptive clinical trials ranging from design planning, monitoring and taking decisions, without compromising the validity and integrity of the results.
- Easily integrates with cross-functional domains like Enrollment, Drug Supply, Interim Analysis and more.
- In a sandbox scenario can easily become an environment for senior management, trial designers and biostatisticians to perform their ongoing design research, what-if or root-cause analysis. Also produces potentially successful models and proposes critical business decisions, while tracking them to capture necessary observations, including process tracking.
Sponsors Management committee, Senior Management, Data Monitoring Committee, Medical Writers, Regulatory Affairs, Quality and Compliance Management, Scientists, Medical Officers, Physicians, Clinical Researchers, Biostatisticians, Clinical Data Management, and other functional users in Pharma, Biotech , Medical Devices and Academia.
eAdaptive is a web based enterprise grade application developed with zero client footprint, available as an enterprise Cloud and also as Software as a Service.
As an end user, all you need is a web browser running on any systems with following minimum configuration.
- Supporting browsers; Mozilla 3.0 or higher and Internet Explorer 7.0 or higher with creation of cookies enabled.
- Running on any flavour of Windows operating system with 1GB of RAM. (Support for Linux will provided in next releases).
- Adobe flash 10 browser plug-in or higher.
eAdaptive is also available for enterprise leasing for your private cloud or in-house deployments. For System Requirements and pricing, please contact sales@maxisit.com
