Get Support That Fits Your Needs
We have expertise in leading complex process change management and implementations. We help with executing strategic initiatives, improving processes, solving regulatory challenges, and aligning with industry trends.
R&D Technology Enablement
Regulated software selection and implementations have a significant level of complexity, uncertainty, and risks. We design and optimize effective processes while ensuring that your technology sources and vendors are going to deliver as promised.
Domain Specific Specialty Consulting
Your business is unique in how you run your business. Leading with industry expertise in specific domains, we can help you to get your complex projects done right and on time.
Regulators Are Urging Companies to Change Clinical Site Monitoring Strategies for Both Sponsors and CROs.
On-site monitoring, with accompanying 100% source data verification (SDV), is resource intensive and estimated to account for one-third of the total cost of a clinical trial. Only 1% of total electronically captured data (EDC) corrections were due to SDV. A plethora of evidence supports changing monitoring strategies, such as using centralized monitoring and implementing advanced analytics tools.
More importantly, you shouldn’t have to worry about delaying your FDA filing because your current monitoring processes are inadequate and cause you to discover problems late in the game.
With Treximo, we can help with your fit-for-purpose monitoring process change to improve CRO oversight, adhere to regulatory guidance, improve data quality and realize long-term cost savings.
Get Ahead of Regulations and Become a Leader in Risk-Based Monitoring.
The FDA issued final guidance in 2013 that recommends sponsors use risk-based approaches to monitor clinical investigations, rather than relying on traditional monitoring approaches. However, there have been signs that Risk-Based Monitoring (RBM) approaches have not yet been widely implemented as part of clinical studies and across development portfolios.
You understand RBM and can’t afford to fail in its execution. At Treximo, we know the challenges, barriers, and enablers that impact the adoption of RBM. We’ll even 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 that you get the monitoring processes that work for you.
Modernize Your Clinical Trials Execution and Oversight by Incorporating Quality by Design Principles.
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 has varied greatly. Such variability has resulted in a variety of sourcing models and approaches to RBQM process development and implementations.
With Treximo, we can support the implementation of your customized solution. This includes building risk assessment and categorization tools (RACT), incorporating quality tolerance limits (QTL), defining key risk indicators (KRI), and integrating with risk based monitoring (RBM) processes.
Incorporate Routine Audit Trail Review Processes to Your Clinical Systems.
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?
At Treximo, we can help you build a strategy and implement customized processes. We can help you to define what data to review by creating use cases, how to review by developing visualizations, and who will review by mapping roles.
Eliminate Inefficient Manual Processes and Become an Automation Leader.
You shouldn’t have to worry about the increasing data volumes and sample throughput along with perpetual changes in technology. If you are seeking to streamline your operation and cut costs, we can help implement a central process to manage and track all aspects of biosamples management. You can deploy a workflow that makes your runs easier to store, track, and assess.
At Treximo, many of our professionals come from scientific backgrounds. We partner with company leaders to get their laboratory process change projects done right while allowing them to focus on what they do best.
We can help with integrating your Laboratory Information Management Systems (LIMS) with instruments and robotics software. We can help with validating your robotics tool while ensuring alignment with the specific nuances and requirements of an experimental design.
Why Choose Treximo?
0Years of experience
Take Your Projects to the Next Level with Treximo.
We lead process designs and implementations while delivering quality results based on your needs.
TransCelerate Initiatives Change Management
TransCelerate offers numerous innovations in improving clinical research. We have successfully translated the new approaches into reality via our implementation services.