Public health and medical research occasionally take unexpected turns that allow us to glimpse new wonders into the world we inhabit. Enlightened by the microbiome, those of us who support biomedical research by providing biological sample management have work to do.
For sponsors, there are numerous operational logistics and regulatory approvals required in order to provide access to their medications through an EAP or CUP. In this case study, UBC deploys a global Expanded Access Program (EAP) to ease the burden on the sponsor and rapidly provide treatment to patients.
In March 2019, the FDA released draft guidance on the design and implementation of natural history studies to support the development of safe and effective treatments for rare diseases that addresses one of the major challenges sponsors encounter when developing therapies for rare disease: the lack of natural history data to guide the design of successful clinical trials. Read more to learn about the important role natural history studies play in drug development and their benefits.
A customer enlisted Catalent to support their child-resistant blister packaging requirements for a global Phase III study. A flexible design was created with an integrated blister card that could also support larger study requirements of 1.9 million monthly dosing cards. Through customized commercial blistering equipment a solution was provided that would accommodate the customer’s growing demands for clinical supplies.
Attracting participants to clinical trials has always been an uphill battle. Social media apps like Tinder is one of the many trends that are reshaping the clinical trial recruiting environment as pharma companies and CROs look for innovative ways to cut time, cost and risk from the recruiting process.
Any capable CRO can provide manpower and execute orders on behalf of a sponsor, no questions asked, with little stake or interest in the endeavor’s ultimate success. What you need is a strategic ally, a company that joins you, lockstep, in pursuing shared goals and greater outcomes. Not a vendor, but a partner.
Understand the concept and benefits of adaptive trials and if they should be a consideration for your company.
Insight on the major issues being raised in the rare oncology space today, including patient perspectives on rare cancer research, innovative trial designs, the regulatory landscape, and pending legislation that may impact how studies are conducted.
Learn the advantages that sponsors and CROs gain when choosing to automate site grant payments.
Rigorous attention to detail is paramount to the successful execution of global clinical trials.
Biorasi builds partnerships with our sponsors. Your challenge is our challenge. We identify with your unique needs and leverage our systems, methodologies, and processes to design optimal solutions specifically for your trial.
Rho is 1 of 5 contract research organizations in the BARDA MCM CSN ID/IQ multiple award task order contract (MATOC) pool that designs and conducts clinical studies needed to develop medical countermeasures—drugs, vaccines, and diagnostic tests—that help protect public health against bioterrorism, pandemic influenza, and other emerging infectious diseases.