Fix, replace or augment: Key considerations for rescue or transition studies in medical device clinical trials.

Clinical trials are demanding, rigorous and time-sensitive. This is especially true for medical device development where the protocols, patient selection or surgical interventions may be highly specific. The demands on all parties – developer, Contract Research Organization (CRO), principal investigator, site staff and participants – are high, so it is little wonder that when a program is not meeting timelines, thoughts of “rescue” or “transition” may need to be considered.

Preclinical oncology renovation

According to a recent study from the American Cancer Society, over 19 million people were diagnosed with cancer in 2020. Cancer reaches every corner of the globe and touches way too many of our lives. And as the search for answers advances, all eyes are on oncology research and this growing drug development field full of new technology and treatment candidates.

Project Management Innovation: Collaboration without Boundaries

Innovation in project management systems is driving a future free of boundaries. Envision a platform that supports COVID-era virtual team collaboration, designed by operations people for operations people. A streamlined, holistic process that offers proactive insights into project health. An approach that makes managing portfolios and projects more intuitive, intelligent and supportive of risk management. We recently shared Labcorp Drug Development insights at the DIA conference; this blog summarizes the discussion.

A macro investment in micro science

The science behind the development of gene- and cell-based therapies is as granular as it gets. Research at this level of precision requires the latest technology, state-of-the-art facilities and expert staff to produce optimal outcomes. In order to schedule more of your cell and gene studies and help you create more therapies to help patients, we have invested an estimated $9.2 million into a comprehensive nonclinical expansion of our Madison, Wisconsin site set to be ready for your studies. This complements other companywide investments dedicated to cell and gene therapy capabilities and support.

Cell and gene therapy answers: Assessing the critical quality attributes, challenges and importance of CMC

Your source for answers to the complex challenges of cell and gene therapy development.

Connecting diagnostic and drug development expertise around the world: Meet Claudine

As the drug development and diagnostic businesses of Labcorp strengthen their combined capabilities, Claudine Rigal, PharmD, Clinical Biologist, Head of Asia Pacific Laboratory Operations and Global Head of Anatomic Pathology Operations for Labcorp Drug Development, is excited about the opportunity to improve service delivery for biotech and pharma clients.

Technologies, tools and processes to support patient-centric oncology trials

There is a gap between the number of patients needed to participate in new cancer trials and the number who give consent to take part. Decentralized clinical trials (DCTs) are helping to address this gap by increasing the reach of clinical studies beyond conventional research sites. DCTs provide an opportunity to remove some of the burdens associated with in-clinic visits, allowing participants to take part in trials from their own homes and/or community healthcare setting, with fewer visits to hospital/trial site. Key to the delivery of DCTs is a suite of tools and technologies that support near real-time review of clinical data from multiple sources. This article looks at some of the technologies, tools and processes that can support more patient-centric oncology trials.

Meeting an Unprecedented Surge in Demand for Kit Production

Supply chain disruptions and manufacturing shortages have significantly affected the clinical trial industry, an issue exacerbated by an unprecedented demand for clinical trial kits. To help maintain business continuity, the Labcorp Central Laboratories team had to develop creative operational solutions at every step of production and quickly accelerate the launch of their new automated kit production facility in Europe.

Uncovering the Regulatory Advice Affecting OECD 443 Study Design and the Impact on Your Ongoing and Future Studies

The Extended One Generation Reproductive Toxicity Study (EOGRTS, EU B.56, OECD TG 443) has been the information requirement for reproductive toxicity under the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH, Annexes IX and X, Section 8.7.3.) since March 2015.

Cell and Gene Therapy Answers: Advancing treatments for pediatric patients with rare diseases

Labcorp’s cell and gene therapy scientific leaders shared their insights on the factors that make rare and pediatric diseases a good fit for cell and gene therapy, along with the key challenges and best practices in this innovative space.