INSIGHTS ON CLINICAL TRIAL PARTNERING

• Supporting The CRA Of The Future

  Learn a few examples of how advancing traditional FSP models can leverage advanced technologies with the power to support CRAs, while making their jobs easier and delivering added value for site staff, patients and sponsors. 

• Clinical Supply Optimization: Process Improvement Accelerates Clinical Trial Deliverables And Execution

  A biopharmaceutical sponsor required the study startup phase to be reduced to 91 days, involving comparator sourcing and blinding, kitting, packaging, labelling and distribution to the sites.

• Proactive Strategies For Meeting NDA Timelines Despite Last Minute Supplemental Study Requests

  With just months left until planned submission of a new drug application (NDA), the Food and Drug Administration mandated a series of unexpected supplemental studies for a new oncology drug.  Having a CRO that is experienced in the common FDA-required studies for NDA submission can make or break the submission timeline. Nimble responses and expert logistics setups can make all the difference.

• Life Sciences Industry Panel Series: Part 3 – Managing Relationships With CROs And Vendors During The Pandemic

  Explore how businesses have been managing their relationships with their contract research organizations (CROs) and other vendors during the pandemic.

• 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.