Clinical Trial System & Processes
We understand clinical trials in all life-cycle stages from planning to submission, and we execute digital transformation changes with excellence to accelerate your R&D value chain. For us, understanding the business, people, processes and data in a regulated life science company is crucial to lead successful changes and realizing the benefits of your pipeline investments.
How we can help you succeed
Expertise within the R&D value chain, clinical operations, regulatory requirements, and compliance is crucial to lead successful projects within the pharmaceutical and life science industry.
Our clients praise us for helping them achieve their key business drivers that will lead their competitive advantages and foster operational excellence like:
- Improved pipeline decision-making for clinical investments in early development
- Faster trial setup, participant recruitment and higher trial participant retention
- Reduction in findings and increased patient safety through trial oversight, monitoring and quality by trial and data design
- Faster database lock for faster decision-making on trial outcomes
- Faster time-to-market submission-packages for drugs and devices
Our tailored services cater to your needs, providing you with consultants who can identify and address your problems in your value chain and achieving excellence operations. To us, navigating and executing your next GxP process, data or digital optimization project from scoping to operations goes beyond a technical implementation – it involves understanding the value drivers, finding the right solution and understanding the process and people within.
Explore how we can help you
Does your digital GxP solution require a fast-paced change, validation and roll-out to business to stay in compliance?
CHALLENGES OUR CLIENT FACE
Sometimes our clients have identified a gap related to a digital solution in their organization that is handling GxP data. The gap could be that it has not been validated or audit findings have been received on failure to comply with regulations and internal procedures. In other cases, the system may be fully validated and in control, however, a new regulation calls for an immediate change to the system followed by validation and roll-out. Often, this causes an urgent need for allocating resources to address the gap causing impact to business operations and already scarce resources.
HOW WE HELP OUR CLIENTS
We assist our clients in ensuring fast-paced release management and validation of GxP and non-GxP solutions without compromising compliance and adherence to regulations. No matter if the validation is yet to be performed or if the attention is to close gaps, we can help you secure that you are in control of your data and that it is fit for purpose for your processes and needs. We facilitate, drive and execute the project from the requirement collection, validation planning and execution to the release management and business roll-out, and we ensure the validation and procedural documentation is compliant and in place to demonstrate control.
Are you looking to introduce risk-based approaches in your clinical operations organization for data handling and trial risk monitoring?
CHALLENGES OUR CLIENT FACE
Sometimes our clients are searching for the ability to predict and manage the potential risk that can negatively impact their clinical trials, when keeping trial data oversight and managing decision on sites and monitoring interventions. They may be looking for or have already implemented a digital solution to enable the ability to go risk-based in their ways of working, however, have lost confidence in the ability for it to be adopted in the organization or bring the intended value.
HOW WE HELP OUR CLIENTS
Risk-based approaches in trial monitoring and data management can bring significant efficiency gains to trial operation organizations by organizing and prioritizing activities based on the risk profile of the individual trials and across the clinical portfolio. However, implementing risk-based approaches is more than simply technology enablers, and we recognize that organizational mindset and process changes primarily drive the realization of the business value. We assist our clients in introducing risk-based methods in their organization from analysis of best-fit processes and digital technology for the data and people, to implementation and business roll-out on a global scale.
Are you looking to optimize a clinical research facility and wondering where to start to get the most out of the investment?
CHALLENGES OUR CLIENT FACE
Sometimes our clients are running clinical trials in a research facility, however, experiencing a challenge in deciding which data and processes that requires digital enablement. Selecting which systems should be invested in to create value for the site can be a tricky affair, and error-prone decisions can be costly and the risk of impacting ongoing trials must be avoided.
HOW WE HELP OUR CLIENTS
We assist our clients in assessing their clinical research facility roadmap from establishment to operations and beyond for continuous improvements and efficiency. We drive and execute user needs and business case analysis, scenario analysis, risk assessments, system implementations (incl. selection, validation, training and roll-out, QMS process development, optimizations and equipment qualifications. We create the transparency required for informed-decision-making of the next big investments and can navigate in a roadmap with the purpose of enabling smoother operations, increasing capacity of the site, enhancing data quality and driving faster delivery of data to sponsor.
Contact Devote Consulting
We analyze each situation and identify opportunities and root causes to introduce changes into your organization with best-fit business processes and associated digital enablement without compromising compliance. Reach out now if you are curious to learn how Devote Consulting can make a difference for you
Our Capabilities & Services
Our consulting experience spans across R&D, Clinical Operations, Pharmacovigilance, Quality, and Regulatory Affairs, with consultants specialized in individual areas and across. We bring the experience and overview that enables us to quickly understand any situation and ensure business and compliance needs are met.
