Alimentiv has an over 30-year successful history in the design and conduct of early to late-phase inflammatory bowel disease (IBD) clinical trials.
The global prevalence of IBD is increasing. Although major therapeutic advances have been made in IBD, no one therapy is effective for all patients, and a large unmet need remains for more efficacious treatments with favourable safety profiles for both Crohn’s disease (CD) and ulcerative colitis (UC). Historically, therapeutic efficacy has been measured by improving disease symptoms. However, clinical remission alone does not reduce the risk of long-term complications, such as surgery and hospitalizations. This contrasts with therapies that induce endoscopic mucosal healing, an objective measure of disease activity that, along with patient-reported outcomes, is recognized by regulatory agencies as a critical component of drug approval trials. Additional objective outcomes, including histopathology, are near-future therapeutic targets.
A vast global network of IBD clinical investigators
Highly trained and experienced central endoscopy, histopathology, and radiology readers with expertise in IBD
Global research consortium focused on operationalizing translational medicine research in multicentre clinical trials
Experienced team of clinical research associates
A suite of standard IBD-specific electronic case report form
Biostatisticians whose expertise in clinical trials ensures high-quality and clinically relevant results
Systematic evaluation of the operating properties of endoscopic, histologic, and radiologic outcomes for both UC and CD
Publication of multiple consensus recommendations and standardized scoring conventions for the most valid and reliable indices for assessing UC and CD disease activity in collaboration with internationally recognized experts
Conclusive evidence for the role of central endoscopy reading in decreasing placebo rates and increasing the statistical efficiency of clinical trials
Development of novel patient-reported outcome measures for UC and CD
Development and validation of the Robarts Histopathology Index, an outcome measure that is routinely used in current drug development programs to assess histologic mucosal healing in UC
Development of the UC-100, a composite (clinical, endoscopic, and histologic) disease activity index intended for early drug development in UC
Development and validation of MAGNIFI-CD, a magnetic resonance-based outcome measure for the radiologic assessment of peri-anal fistulizing CD activity
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