INSIGHTS ON CLINICAL TRIAL PARTNERING

  • Best Practices In Site Feasibility Studies Can Set the Stage For A Healthy Trial

    Well-performed site feasibility can become the single most important factor in reducing costs and time spent in a clinical trial. With adoption of benchmarking and clinical trial tools, sponsors are able to know exactly how many sites they need in their trial, which makes site pre-identification essential for efficient study start-up.

  • Automatic Score-Based Treatment Path For Site Users

    A biopharmaceutical company had a Phase II study with 300 patients in 5 countries. At a key point in the study each patient’s treatment path depended on a score calculated from data collected over the previous period. Cmed was able to provide them with a solution that would enforce a workflow to ensure the accuracy of the data used in the score calculation.

  • Rolling Start-Up Key In Global Observational Cohort Study For Patients With Psoriasis

    A large biopharmaceutical company needed to manage a 5 year observational cohort study for patients with moderate-severe psoriasis who are initiating or switching to a new biologic. Read how UBC successfully managed global observational study with customized service offerings.

  • Infectious Disease Teams

    A not-for-profit Sponsor requested assistance with monitoring in an Ebola hot spot at trial naïve sites with little experience. Ultimately, the study required rapidly deploying solutions across diverse geographies. Read how the quick response and the geographic alignment of the team enabled the study to be completed.

  • Identifying The Best People To Run A Clinical Study (And How To Hire Them)
    6/15/2021

    No matter how brilliant a clinical trial process or a technology may be, it is useless without skilled, motivated individuals at the helm.  

  • Reading Regulators' Minds: Avoid NDA Approval Delays By Anticipating Clinical Pharmacology Studies
    6/29/2020

    In this on-demand webinar leading experts discusshow to proactively plan for NDA approval.

  • Leveraging eRegulatory To Improve Remote Monitoring
    6/23/2020

    Remote monitoring technology initiated by sponsors can often inflict additional burden on sites, requiring them to not only print and file their regulatory documents, but scan and upload them to multiple sponsor portals, too. Fortunately, sites are beginning to identify more efficient ways to enable remote monitoring.

  • Conducting Successful Site Qualification Visits Using Virtual Solutions
    8/25/2020

    With decentralized trials as a mainstay of the current clinical research landscape, it’s imperative to leverage the virtual resources available to cultivate meaningful evaluations and assessments, safeguarding patient safety and data integrity. Read how a CRO conducted site qualification visits virtually, which required creating hybrid approaches to utilizing our virtual platforms.

  • Prostate Cancer Clinical Utility Study
    1/2/2020

    To further enhance their prostate cancer test, a multinational healthcare company needed to compare its non-invasive urine test against biopsied tissues. But the logistics of identifying 2,000 patients and collecting tissues at 21 US urology centers within 6 months was daunting. Read how quick response by Catalyst and the geographic alignment of the team the study was completed within a short window of time.

CLINICAL TRIAL PARTNERING SOLUTIONS

  • Medidata Adjudicate is part of the Medidata Clinical Cloud™, and offers a cloud-based, end-to-end solution, with easily configurable modules enabling quick setup to manage endpoint adjudication in clinical trials. Medidata Adjudicate supports investigator sites, sponsors, CROs, data managers, and the CEC in collecting, managing, organizing, adjudicating and submitting clinical endpoint data.

  • We have created a flexible sourcing approach that gives operational teams the benefit of our clinical research expertise and access to our extensive resources. Our functional service provider (FSP) model lets you control and fine-tune your level of involvement so you have full flexibility in deciding how hands-on (or hands-off) you want to be.

  • Cmed is highly experienced in the management of cell and gene therapy clinical trials, whether in oncology, rare diseases or other therapeutic areas. Cmed is the best choice to manage complex cell and gene therapy trials and has worked with multiple sponsors on treatments for oncology and rare diseases. Our experience includes CAR-T cells, HSC, autologous Gamma-Delta T Lymphocytes, Adenovirus vector-based gene therapy etc.

  • Worldwide Clinical Trials' award-winning, specialized early phase oncology team helps emerging and established biopharma, biotech, and pharmaceutical companies accelerate the advancement of early phase compounds through clinical testing.

  • Site payments are not easy. They are frustrating, burdensome and a drain of time and resources. A site’s inability to receive payment accurately and quickly is the result of manual, siloed processes across the entire study.