ABOUT CATALYST CLINICAL RESEARCH

Catalyst Clinical Research is a clinical development organization providing highly customizable solutions to the global biopharmaceutical industry. Built from more than two decades of listening to their customers, devising customer-centric solutions and helping them breakthrough with clinical development programs surrounded by therapeutically aligned teams of experts. Catalyst provides solutions for global resourcing, FSP and full-service clinical trials with a focus on oncology therapeutics.

Catalyst Clinical Research has locations in the US and EU and is a portfolio company of NovaQuest Capital Management, LLC, a leading healthcare and life sciences investment firm. For more information, please visit www.catalystcr.com.

FEATURED ARTICLES

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

  • Clinical Data Management

    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.

  • Safety Services

    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

  • Team Augmentation

    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.

  • Study Rescue Teams

    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.

  • Project Teams

    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.

  • CRO Oversight

    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.

  • Oncology Site Network

    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.

  • Oncology CRO

    With a personal passion to help find a cure and a cultural tenet to be exceptional in one area versus mediocre in many, we have expanded our biometric and clinical operations offerings to include a full service, end-to-end solution. And with access to Catalyst’s robust, global network of veteran oncology clinical monitors, we can assure 100% therapeutic and
    geographic alignment. Where else have you received that promise?

  • Global Resourcing

    A great team doesn’t happen by accident. It all begins with listening to your criteria. Then we engage the industry’s best and brightest clinical research professionals to support your development programs. With Catalyst, you will never get “anyone who’s available” because we hand pick each professional based on the expertise required, the scope of work and your desires. In fact, we involve you in the team selection process to ensure the right fit for you.

  • Functional Service Provider

    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.