INSIGHTS ON CLINICAL TRIAL PARTNERING

  • Effective Way To Ensure Early Statistical Deliveries
    4/7/2021

    A biopharmaceutical company had a first-in-human study in patients with solid tumors. They were in need of regular and timely reports to provied to the Safety Review Committee for dose decisions, to support rapid study completion. Cmed offered a solution by building an encapsia database to enable the sites to quickly enter their data and developed a robust and flexible set of programs to generate outputs required by the Safety Review Committee.

  • The Secret To Achieving A Smarter Long-Term Clinical Data Strategy
    5/17/2021

    There is a tendency for sponsors to view data management and analysis as a commodity business – something that one Contract Research Organization (CRO) can do as well as another. But the truth is, it demands a level of expertise and attention that is not always available in CROs for whom it is not the core component and specialty of their business.

  • Preparing Monitors For Tomorrow’s Clinical Trials
    2/11/2021

    CRAs have a difficult job – from the extensive travel to the tedious time spent preparing for onsite visits and completing trip reports. 25%-30% of total clinical trial costs are attributed to site monitoring, however, this can be streamlined with a risk-based approach.

  • Mitigating FSP Talent Shortfalls Through Development
    6/27/2022

    Clinical research is in the midst of a serious talent shortage. Shortages have been particularly noticeable within FSP, a model that offers incredible resource flexibility to sponsors but that often requires us to staff up quickly. This blog shares tips and best practices to attract and train new employees and upskill and retain the staff members we already have.

  • Global Advantage With Free Trade Zones In China
    7/14/2022

    Learn more about how free trade zones work, and explore a flexible and cost efficient way to supply clinical trials in China and around the globe.

CLINICAL TRIAL PARTNERING SOLUTIONS

  • Source data verification (SDV) is a critical activity within clinical trial monitoring, yet the traditional approach focused on 100% SDV is limited in its ability to quickly identify issues and prevent them from recurring. Rave TSDV (Targeted SDV), unified with Rave EDC, enables CRAs to focus on critical to quality (CtQ) factors identified within risk management activities.

  • Our RegOps team offers document-level publishing or management of the entire regulatory submission process. Coupled with our electronic document management system (Veeva), we can oversee all technical aspects for submission of your dossier (eg, eCTD document granularity, utilization of content templates, document formatting, hyperlinking, bookmarks, navigation, publishing, and redaction services). Our technical editing team offers a unique and specialized skill set that include some of the savviest in the industry.

  • Discover inSeption Group's eTMF success process designed to ensure your critical eTMF documents and content are secure, organized, readily accessible, and always in complete compliance with all relevant regulations.

  • Worldwide Clinical Trials has extensive experience in rare disease and pulmonary arterial hypertension (PAH) trials, which is derived from our global PAH trial experience and enhanced by our medical and scientific understanding of unique PAH trial requirements.

  • We manage all aspects of contract and template development, alternative language and budget parameter development, contract negotiations and execution, as well as investigator grant payment administration and patient reimbursement.