Our Services
Find below the range of services which TRICALS can support for companies.
Interested in collaborating? Contact us!TRICALS' MAGNET
TRICALS now also offers MAGNET (Multi-Adaptive Global Network of Efficient Trials), combining our services into one. MAGNET offers to perform innovative, cost-efficient phase II and III clinical trials for the pharmaceutical industry, uniting our scientific rigor with operational excellence.
Study awareness
TRICALS’ site network consists of an outstanding network of large experienced ALS centres which are trial ready. Our TRICALS sites are characterized by high patient enrollment and dedicated research staff. All sites have an established track record in industry- and investigator-initiated trials ranging from phase I to pivotal phase III trials. The TRICALS operations office supports both sites and sponsors during the recruitment phase in keeping the recruitment on target. TRICALS supports sponsors on their study awareness by publishing the trial on the TRICALS website and informing the TRICALS and ENCALS network, patient organizations and patients on the trial.
Recruitment
ALS patients from all over the world are registered in our registry via the TRICALS website. To recruit patients for trial participation in the study, eligible registered patients will receive TRICALS newsletters containing information on your trial, in- and exclusion criteria and information on which centres are recruiting. Patients can directly contact recruiting centres through the TRICALS website.
Site feasibility/selection
With currently more than 60 experienced TRICALS sites across Europe, we can perform site feasibility and selection based on preferences of the sponsor. TRICALS supports sponsors on site selections based on extensive knowledge about (global) ALS centres, track records, reliable recruitment targets, insight about competing trials. TRICALS knows the startup hurdles of all sites and the peer-to-peer relationship between TRICALS and the sites is of great importance to ensure a smooth and fast site selection.
Protocol/study design
TRICALS supports sponsors with protocol and trial design. With many years of experience in setting up ALS clinical trials, an EMA approved protocol, collaborating with many companies, TRICALS stands at the leading edge of the field, possessing knowledge about the latest advances of the ALS field and adopting state-of-the-art practices. With our statistical expertise we support sponsors on creating evidence-based, innovative study protocols. TRICALS strives to combine robust design with hard endpoints, and produce high-quality data. With smart trial design we aim for targeted and increased inclusion through a validated survival prediction model. We use innovative biomarkers and improved composite endpoints.
Regulatory submission support
TRICALS, being in the ALS field for many years, has specialized knowledge of this highly complex disease. We offer support to sponsors and CROs during the submission to ethical committees, FDA/EMA questions and/or grant applications.
TRICALS Academy
The TRICALS Academy provides high quality training by experienced trainers on outcome measures, such as Harmonized ALSFRS-R, Kings Staging, Respiratory function, ENCALS Risk score & Electrophysiological assessments. Sites and sponsors can request certified training in specific outcome measures for ALS trials.
Site management
TRICALS has extensive experience in site management. To ensure a smooth and rapid enrollment, TRICALS supports sponsors, CRO's and the participating sites from the start of the trial. During the recruitment and follow-up phase, sites and CRA's can reach out to the TRICALS project team to discuss items such as protocol questions, query resolution, handling outcome measures, low(er) retention rates, lack of quality during follow-up visits, unresponsiveness of sites or any kind of hurdles at site or between site and CRA/sponsor/CRO.
