Listening To – and Learning From – the Voice of the Patient

Patient recruitment represents the biggest challenge in clinical trials. From general patient identification and participation to reducing screen failure rate or limiting patient drop out after enrollment, drug developers face many massive pain points to initiate their clinical trials.  

Patient recruitment and retention continue to be the biggest challenge in clinical studies. Designing protocols with patient needs in mind will lead to higher levels of better clinical research recruitment, drive up participation rates and save both time and money.

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Future-Proofing Residue Analysis Services

As the regulatory landscape across the globe is rapidly evolving, more sophisticated requirements must be met by registrants and scientists. In parallel, scientific advances have impacted previous methodologies that were once seen as cutting edge but now may fail to adequately address new regulatory challenges.

Clients should consider techniques to future-proof their studies to flexibly adapt to pre- and post-registration regulatory and scientific environments and keep up with trends in the crop protection market.

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Meet me in 5: Promoting Career Growth at Covance China

Our “Meet Me in 5” series covers 5 people, topics or questions to illustrate how our business nurtures exceptional people, provides an energizing purpose and enables extraordinary potential in its employees’ careers.

In this article, we spoke to Linda Qiu, Executive Director, APAC HR Partnering, based in Shanghai. She shared how Covance has helped grow her career and how she is working to help her colleagues to advance in their own careers at the new location in the Aland Center.

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Real-World Evidence Applied in Real-Life Case Studies

Real-world evidence (RWE) can be used to meet different objectives, and RWE studies can be designed using different study types and methodologies, as well as multiple sources of real-world data (RWD). Teams often work separately and could benefit from a shared learning experience in the planning and execution process. A publicly-available RWE framework tool was recently released to help enhance collaborative efforts in RWE studies.

Clinical Trial Data Xcellerate Informatics Covance Blog

Earlier blogs in this series discussed closing the knowledge gap with RWE studies and how Covance and industry professionals worked to develop an RWE framework tool. This third and final blog further explores how the tool was applied in actual case studies to better support RWE efforts in treatments for diabetes and pain management.

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Customizing Real-World Evidence (RWE) Study Designs: A New Framework Tool That Incorporates Elements of Virtual Study Design

While assisting clients with their clinical development plans, and post-marketing studies, our team is witnessing a trend in designing RWE studies with both traditional and virtual elements. With growing interest in hybrid designs, Covance is exploring how we can help our clients incorporate their study objectives while evaluating a range of alternative options for evidence generation that enable faster, less resource intensive and more patient-centric, study execution.

In this second article in our series of three, learn how we collaborated with RWE professionals to create a unique RWE framework tool that can help your teams with study planning in today’s rapidly evolving environment.

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5 Ways We’re Recognizing our LGBTQ Employees and Allies through our PRIDE Network

Covance and our parent company LabCorp celebrated Pride Month in June, and our commitment to building a culture of openness and inclusion continues throughout the year. We recently caught up with members of our PRIDE Network and learned about some recent events and upcoming plans, such as the Indy Pride 2019 Career Fair, to strengthen our outreach.

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Meet Me in 5 – Improving Internal Mobility

Our “Meet Me in 5” series covers 5 people, topics or questions to illustrate how our business nurtures exceptional people, provides an energizing purpose and enables extraordinary potential in its employees’ careers.

In this article, we spoke to Phui Sie, Team Manager for Global Project Management based in Singapore. She shared her own career growth story and discussed how she helps her team members advance in their careers and find new growth opportunities at Covance.

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Using Data Visualization Tools on SEND Datasets: A Graph is Worth a Thousand Data Points

SEND [Standard for Exchange of Nonclinical Data] is more than just a tool SEND test submission with Covance. Photo of binary codeto facilitate nonclinical data submissions to the FDA. SEND datasets are rich in information, albeit in a form that’s time-consuming for non-experts to parse. With the right visualization tools, SEND data sets can inform nonclinical programs and yield important insights.

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What’s Changing in SEND 3.1?

The SEND [Standard for Exchange of Nonclinical Data] Implementation Guide v3.1, “SEND 3.1,” changes the model for the reporting of cardiovascular and respiratory endpoints.

SEND 3.1 became effective 15 March 2019 for NDA/BLA submissions; and it will become effective 15 March 2020 for IND submissions, overlapping with the effective period of the previous version, SEND 3.0. (See chart below.)

SEND 3.0 and 3.1 roll-outs

Chart 1. SEND 3.0 and 3.1 roll-outs.

Some additional regulatory considerations during this transition period include:

  • The SEND version required for your submission is determined by the study start date (aka protocol finalization date).
  • If you are including non-GLP studies in a regulatory submission, a SEND dataset is also required.
  • If you have legacy studies in your submission, an abbreviated TS file (Trial Summary file) is required for each one.

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Meet Me in 5 – A Commitment to Career-Building

Image of Kim Radovan and Christine Rieser B

Our “Meet Me in 5” series covers 5 people, topics or questions to illustrate how our business nurtures exceptional people, provides an energizing purpose and enables extraordinary potential in its employees’ careers.

In this article, two leaders from our Global Talent Management group shared their thoughts on our commitment to learning, the learning resources available to employees, and how to take advantage of opportunities to grow and develop – at every stage in your career. Continue reading