ABOUT CATALYST CLINICAL RESEARCH

Catalyst is a clinical development organization providing highly customizable clinical research solutions to the global biopharmaceutical industry through two established solutions: Catalyst Flex and Catalyst Oncology. With over 500 staff and offices in the US and EU, the company provides multi-therapeutic global resourcing and functional services through Catalyst Flex and a full-service oncology CRO offering through Catalyst Oncology. The company’s flexible service model is built from more than a decade of listening to customers, devising customer-centric solutions, and helping them drive breakthrough clinical development studies leveraging Catalyst’s expert teams and innovative technologies.
 
Catalyst is a portfolio company of NovaQuest Capital Management, LLC, a leading healthcare and life sciences investment firm.

FEATURED ARTICLES

Tune into the below webinar where Vice President, Catalyst Flex Growth Strategy, Betsy Brown, and Senior Vice President, Resourcing Operations, Kathy Bradrick discuss with guest speaker, Maggie Neptune, key outsourced staffing strategies needed by mid-tier biopharma and life sciences companies to achieve study success before, during and in the wake of the pandemic while gaining a sponsor’s perspective on the benefits of a flexible resourcing model.

Clinical research has evolved throughout the COVID-19 pandemic as the industry has embraced new tools and techniques. Now, sponsors and their CRO partners must determine which solutions remain viable for long-term, post-pandemic success.

A not-for-profit Sponsor requested assistance with monitoring in an Ebola hot spot at trial naïve sites with little experience. Ultimately, the study required rapidly deploying solutions across diverse geographies. Read how the quick response and the geographic alignment of the team enabled the study to be completed.

The usual approach of adding technology and headcount to manage today’s clinical trials is not sustainable or scalable. In this webinar, Nick Dyer (CEO, Catalyst Clinical Research) discusses the challenges his team has experienced with complex early phase oncology studies, and why they chose Medidata’s CTMS to help Catalyst attain operational success.

To further enhance their prostate cancer test, a multinational healthcare company needed to compare its non-invasive urine test against biopsied tissues. But the logistics of identifying 2,000 patients and collecting tissues at 21 US urology centers within 6 months was daunting. Read how quick response by Catalyst and the geographic alignment of the team the study was completed within a short window of time.

Adaptive designs allow more flexibility and control over the trial and, hopefully, will lead to defining the optimal strategy for the given therapy. Bayesian statistics is likely to dominate the future standard of trial design but does involve change in how clinicians interpret the results.

A small biotech was purchased by a large multinational biopharmaceutical company and shortly thereafter closed the office of the former, leaving little to no resources for ongoing statistical programming to ensure continuity for their robust clinical development programs. To ensure limited disruption of the program, the Sponsor engaged Catalyst to assume statistical programming services as they had no internal resources to dedicate. With Catalyst proving the ability to scale and provide exceptional programming talent the partnership continues to expand.

A small biotech with limited internal capacity outsourced a phase III clinical program in patients with Necrotizing Soft Tissue Infections. After nearly 16 months, patient enrollment was still a major challenge, the study was over budget and CRO staff turnover on the project was extremely high. Catalyst provided a blinded and unblinded monitoring team that reported into the Sponsor’s CTM using Catalyst’s SOPs allowing the Sponsor to retain control of their program.

To ensure compliance with the updated ICH E6 (R2) guidelines and to address internal capacity issues, a midsized biopharmaceutical Sponsor required qualified support to help ensure appropriate oversight of several large, global CRO providers. By embedding an oversight team within the Sponsor’s team Catalyst was able to alleviate a backlog of activities, while providing effective CRO oversight.

A mid-sized multinational biopharmaceutical company opted to internalize the study management and execution of their Phase Ib/II multicenter oncology program. As a result of positive treatment outcomes, patients continued in the trial for significantly longer than originally projected, creating a large data backlog that required source document verification. Read how strategies were deployed to obtain data currency and obtain management oversight to meet the program's expansion.

CONTACT INFORMATION

Catalyst Clinical Research

5826 Fayetteville Road, Suite 202

Durham, NC 27713

UNITED STATES

BROCHURES

  • Catalyst Oncology is a niche Oncology CRO devoting time, energy, and capital to supporting biotechs in bringing next-generation therapies to cancer patients in need. Oncology clinical research is complex, demanding, and continually evolving. Bringing effective therapies to proof-of-concept and then to market as fast as possible is our mission because every second counts for patients and their families living with cancer.

  • Catalyst Flex creates "fit for purpose" multi-therapeutic resourcing and functional solutions to support life sciences companies in developing patient-centric therapies for patients in need. Based on more than a decade of clinical research experience, our customized services are built on a flexible and scalable model providing enhanced capabilities and ensuring study success.

  • Clinical Data Management performs a critical process for data collection, processing, and reporting for your clinical trial. The Catalyst tight-knit teams are easily accessible and have frequent and direct contact working on your study from day one and continuing through the life of your project. Let us take a proactive approach in identifying an optimal solution based on your needs ensuring reliability and integrity of data for on-time deliverables and database locks.

  • Are you seeking a partner with a proactive approach to lifecycle safety management of pharmaceutical products and devices? Consider Catalyst knowing that our goal is to provide quality and compliance in all aspects of pharmacovigilance

  • If you need to add a single resource or a few people to round out your team, we’re here to supplement your resourcing needs for both short-term and long-term assignments. We offer part-time and full-time staff to help bolster your team in the areas of clinical operations, data management, biostatistics, statistical programming, pharmacovigilance, medical writing, and regulatory affairs.

  • When your study is in trouble, finding the right team to effectively mitigate complex challenges is vital to a successful outcome. Catalyst can create flexible solutions that bring your study back into balance with our experience across a range of therapeutic areas.

  • Catalyst Project Teams provide you with customized resource solutions that are tailored to your specific requirements. Whether it’s a monitoring team with a lead CRA, or a team of SAS programmers to support your submission, we have the expertise to build the right team for you within the timeframe you require.

  • To be compliant a sponsor needs to ensure that proper CRO oversight is being provided. Ensuring compliance can be particularly difficult for small and emerging biopharma organizations who are virtual or are looking to stay nimble. Don’t be fooled into thinking that your fully outsourced study is enough.

  • Investigative sites are the centerpiece of a successful clinical trial, but more often than not, sites are treated like a third spoke in a wheel. At Catalyst, we place a high value on the partnerships our sites and other study collaborators bring to ensure a successful clinical trial, resulting in new terapies for those battling cancer.

  • Functional Service Provider (FSP) partnerships have been gaining traction in recent years because of their potential for increasing efficiency in outsourcing without compromising quality. At Catalyst, we know that FSP means different things to different people because there is no one solution. We customize each and every FSP solution to leverage your legacy systems, established processes and procedures, and development pipeline in order to maximize efficiencies.