Escalating R&D costs and shorter lifecycles, combined with increased risks, are having a negative impact on the return on investment and productivity returns for life sciences companies.
As the future approaches quicker than the industry expected, each organization within the clinical trial lifecycle is faced with the same dilemma: expand and grow with technology or shrink and be left behind.
An Organizational Change Management (OCM) strategy ensures that you are equipped for successful technology user adoption as your organization begins to expand to embrace digital transformation.
R&D Technology Enablement
Regulated software selection and implementations have a significant level of complexity, uncertainty, and risks. ProPharma Group designs and optimizes effective processes while ensuring that your technology sources and vendors will deliver as promised.
Clinical Trials Monitoring Change Management
Our skilled and well-trained experts ensure the integrity of clinical studies, adherence to protocols, quality of measurements, and safety of the subjects. During our on-site monitoring visits, we:
Risk-based Monitoring Implementation
Clinical monitoring can account for up to 50% of study costs. To help reduce the high costs, Risk-Based Monitoring (RBM) moves away from the traditional approach of frequent on-site visits and 100% source data verification (SDV) toward a combination of activities, including centralized data collection and monitoring. However, Sponsors and researchers have been slow to implement adaptive strategies and much of the industry is struggling to implement RBM.
At ProPharma Group, we know the challenges, barriers, and enablers that impact the adoption of RBM. Our team of experts can help find opportunities to improve your RBM implementation and ensure its success.
We can build customized and adaptive RBM processes to support reduced SDV, improve on-site monitoring, design remote (off-site) monitoring, or incorporate centralized monitoring. We can also help with procuring and enabling the right technologies so you get the monitoring processes that work for you.
Risk-based Quality Management
As clinical trials become more complex, regulatory authorities have pushed life sciences organizations to identify proactive ways to design quality into clinical studies design rather than taking reactionary approaches. Risk-based quality management (RBQM), rooted in Quality by Design (QbD) principles, offers the solution. This approach encourages a cross-functional, holistic, and risk-based approach to clinical trial management and oversight.
While regulatory guidance provided core requirements, interpretations have varied greatly. Such variability has resulted in a variety of sourcing models and approaches to RBQM process development and implementations.
ProPharma Group’s RBQM solution helps clients identify, capture, and manage quality issues at the earliest stages of emergence before potential risks escalate into liabilities.
Our proven model includes:
- Building risk assessment and categorization tools (RACT)
- Incorporating quality tolerance limits (QTL)
- Defining key risk indicators (KRIs)
- Integrating with risk-based monitoring processes
Clinical Data Integrity in Audit Trails Solutions
Audit Trail Review Process is a component of data integrity to ensure trustworthiness and reliability of data submitted to the regulatory authorities. According to regulatory guidance, organizations are being urged to develop an overarching and practical methodology to perform routine reviews of audit trails in clinical systems used for study data.
Audit trails generate millions and billions of data points. Do you know what to review and how to review such massive amounts of data?
ProPharma Group can help build a strategy, implement customized processes, identify review data, develop visualizations, and map review roles.
Automated Laboratory Informatics and Analysis Solutions
The amount of data produced by an average R&D laboratory can be overwhelming. In order for labs to gain maximum value from data in a realistic time frame, data processing and analysis technology must keep pace with automation innovation.
At ProPharma Group, we help our clients implement automated laboratory informatics and analysis solutions to increase throughput, reduce human error, boost productivity, and save time and money.
Our informatics business solutions have helped leading companies integrate Laboratory Information Management Systems (LIMS) with instruments and robotics software. We can help validate your robotics tool while ensuring alignment with the specific nuances and requirements of an experimental design.