Ready to Meet Your Needs
At TRIO, we’re flexible, nimble and connected to the needs of our partners—from early phase to registration trials. With an engaged and growing Investigator Network, the consistency of a worldwide study team and an exemplary Scientific Committee, we offer full-service solutions to bridge geographical gaps on a global scale. At the same time, our tactical processes and cutting-edge systems allow us to conduct large-scale trials with worldwide impacts. The result? Cancer drugs that get to clinics and patients faster.
Working as a true partner, TRIO Project Managers organize, plan and execute clinical trials to meet our Sponsors’ timelines and budgets.
Experienced and engaged, our Project Managers have significant expertise in cancer clinical trial management, including registration trials. They work smoothly and seamlessly, leveraging our global systems, processes, tools and reports to anticipate the next steps in the study process and proactively manage any issues.
Our Project Managers demonstrate flexibility, innovation and the willingness to meet Sponsor needs and new requests. They:
- Offer a single point of contact for our partners while coordinating with TRIO’s multidisciplinary operational team
- Provide clear and efficient project planning and monitoring of the project plan
- Problem-solve to rapid identification, solution proposal and solution implementation
- Deliver quality oversight, including but not limited to trial documentation, training coordination, data quality and compliance oversight
Site Feasibility and Activation
To reduce timelines and increase efficiencies, TRIO’s Clinical Start-up Unit (CSU) identifies, selects and activates the Investigator sites for every study.
For each trial, TRIO CSU selects Investigator sites from TRIO’s top-tier network of Investigators and works with the Project Management team to consolidate the trial enrollment plan. For each site, a single team member is accountable for coordinating all country and site-level tasks leading to site activation. These include, among others, coordination of submission activities to Ethics Committees/IRB and Competent Authorities, as needed.
TRIO CSU understands the startup phase of cancer clinical trials is dynamic. We’re ready to strategically react and adapt to moving targets, providing:
- Access to a pre-qualified, international network of oncology Investigators
- An activation owner for each site, who’s responsible for developing the activation plan and coordinating all activities up to the site initiation visit
- The agility and tactical ability to quickly adapt as the trial is implemented
- Country-level and site-level best practices for rapid site activation
The Data Management (DM) team is responsible for database set-up, testing and maintenance for cutting-edge oncology trial management. The Case Report Form (CRF) provides the backbone for the database build process. Our TRIO DM team has extensive experience in CRF design and interacts with relevant parties to ensure the CRF captures all necessary data points, in accordance with the protocol and statistical analysis plan.
Using the Medidata platform (RAVE EDC / CODER), our DM team implements the required standards (e.g., CDISC), manages data coding through validated dictionaries and coordinates data imports, exports and transfers.
At TRIO, data review and cleaning are collaborative efforts, which take advantage of the expertise of Project Management, Medical Affairs, Drug Safety, and the local support of the Monitoring team. Our DM team supplies:
- Access to the TRIO library of Case Report Forms and Edit Checks, specifically designed for oncology trials
- Expedited CRF design and database build
- Investigator-friendly and widely accepted EDC (21 CRF part 11 compliant)
- Registration-ready data management processes
TRIO’s Clinical Research Associates (CRAs) ensure ICH/GCP compliance, data integrity and protection of patients’ rights at each Investigator site.
They have strong scientific backgrounds and extensive experience in clinical trial methodology and oncology. The excellence of their work demonstrates their commitment to professionalism and innovative problem-solving.
Our highly experienced CRAs are the primary point of contact for the Investigator sites, driving site performance in every clinical trial. When they join a study, each CRA participates in a rigorous, comprehensive, and extensive training program to ensure consistency in clinical research monitoring. Our CRAs:
- Have at least two years of experience in oncology
- Are locally based to optimize time spent on site
- Provide on-site and remote site monitoring
- Can utilize a Risk Based Monitoring (RBM) model
- Have low turnover rates
TRIO’s medical team includes experienced medical oncologists, most of whom are practicing physicians.
They’re a key part of the trial team and are involved from study conception to results presentation. Their contributions to the trial team include training, medical review of data, medical monitoring, safety signal detection and more.
The Medical Affairs group is also responsible for TRIO medical writing activities including protocol, Clinical Study Report (including patient narratives) and trial publications. TRIO offers:
- Medical oncologists for medical monitoring and medical writing for clinical trials and activities
- Max 1-day TAT for medical inquiries
- 24/7 coverage
Drug Safety and Pharmacovigilance
TRIO’s Drug Safety Unit ensures drug safety in clinical trials, including maintaining the safety database, processing Serious Adverse Events (SAEs) and safety reporting.
The team is made up of experienced and detail-oriented individuals who are dedicated to patient safety and improving patient outcomes in our oncology trials.
The flow of safety information is critical to ensure compliance with regulatory timelines. TRIO has its own solutions to successfully manage these processes (PV247 and MARS). The DSU team may also leverage solutions from our clients to optimize efficiency. TRIO’s Drug Safety Unit offers:
- SAE reception, triage, and case review
- Timely reporting of safety information to applicable entities (sites, ethics/IRB, Competent Authorities)
- An oncology-trained team
- Signal detection
TRIO engages renowned statistical partners and their teams of biostatistical experts, to support clinical trial protocol writing, development of the Statistical Analysis Plan (SAP), programming of statistical outputs (tables, listing, graphs), as well as generation and interpretation of trial results.
TRIO can manage the distribution of drug supplies internationally, through a preferred partner.
For any given trial, TRIO can help determine the amount of supplies required and/or propose the most efficient distribution processes depending on the regions considered. Our expertise includes:
- An Interactive Web Response System (IWRS)
- Regional depot(s)
- The import of drug supplies
TRIO leverages its relationships with academic partners (or other preferred vendors) to propose solutions related to:
- Preclinical testing (in vivo/ in vitro)
- Central testing (patient samples)
- Sample collection kits
Our people set us apart. We’re leading experts in oncology trial conduct. We take pride in our work and strive to provide innovation through science in all aspects of our operations.
At TRIO, we continuously leverage technology to optimize trial execution. Our Medidata Clinical Cloud platform (including RAVE Electronic Data Capture (EDC)), our Clinical Trial Management System (CTMS), our Strategic Monitoring module and the electronic TMF facilitate trial execution and progress reporting. They also enable faster availability of data to Sponsors.
What’s more, TRIO recently deployed the elluminate® platform to optimize the review of clinical data and create an automated site payment system.