- an agent that provokes or speeds significant change or action
- a person or thing that precipitates an event or change
- a valued clinical research partner
The Right-Fit Outsourcing Partner for Biopharma
Since our inception five years ago, Catalyst has become known for meeting the operational challenges of biopharmaceutical and medical device clinical research programs through innovative, cost-effective, and highly collaborative solutions.
In response to customer demand, we are delighted to announce Catalyst’s enhanced services offerings, a result of our leadership team expansion and merger with Triangle Biostatistics (Tri-Stat), a leading provider of biometrics solutions to the clinical research industry.
With this expansion, Catalyst is now able to offer significant functional expertise in data management; biostatistics; SAS programming; and regulatory, medical, and safety services to complement the clinical monitoring, site management, and project management solutions Catalyst has successfully delivered since its inception.
We now offer an array of services through three delivery solutions options which may be deployed in any combination to help support our customers’ clinical development programs:
- Strategic Resourcing Solutions
- Functional Service Provider/Workforce Solutions
- Catalyst Managed Study Solutions
We deliver all services under a Fit-for-Purpose model customized to meet your unique needs and the study’s distinct requirements, not a CRO “black box.”
Although Catalyst has expanded the depth and breadth of our reach, you can rest assured we will continue to hold fast to the core tenets by which we’ve always been known: Integrity, Transparency, Flexibility, Responsiveness, and Customer Service. We invite you to learn more about us on the following pages and links.
STAY TUNED…MORE EXCITING NEWS IS AROUND THE CORNER!
As co-founders and principals, Betsy Brown and Jean Hendrickson created Catalyst to fill a substantial gap between clinical research staffing and full-service CRO core offerings. Their vision was to bring flexible and purposeful clinical operations solutions to the industry, specifically geared toward small-to-medium size development organizations desiring flexible options in their outsourcing solutions. This approach was well received by customers who had often grown frustrated with “black box” service providers and their one-size-fits-all approach, inattentiveness, and lack of transparency.
Our customers were asking us to move beyond clinical operations and clinical monitoring, so in late 2018 Catalyst began to expand its vision and add significant expertise and capacity to our leadership team. Then in February, Catalyst formally merged with a culturally like-kind company — Triangle Biostatistics — an industry leader in biometrics solutions. With Triangle, we bring to our customers leading expertise in data management systems and processes, biostatistics, SAS, and Data Standards and CDISC, as well as an awesome, talented team!
With organic and acquired growth, 2019 marks the launch of our new multi-solution CRO providing a range of clinical development support services purposely structured so you can customize the level of support for each study, what we term Fit-for-Purpose Solutions.
- Our Strategic Resourcing Solutions provide access to highly experienced staff through flexible, budget-friendly assignment models.
- Our Functional Service Provider/Workforce Solutions allow you to utilize Catalyst functional expertise across studies to maximize economies of scale while embracing our “extension of you” philosophy.
- Our Catalyst Managed Study Solutions employ our highly experienced, tenured staff and leverage an oncology-specific therapeutic focus, hands-on management system, and the use of innovative technologies to enhance study execution and make informed decisions. Your study will also benefit from an exceptionally low rate of in-study staff changes.
Global Head, Commercial Operations
Kathy heads up Commercial Operations for Catalyst and is a proven clinical research business leader. Her career spans more than 25 years and includes leadership roles at large and small CROs, as well as pharmaceutical and government research organizations. She has founded and grown a niche CRO, led an international clinical services company, driven integration of a global multi-company merger, directed global recruiting, built departments and teams, guided process development and improvement, and led business operations functions including proposals, contracts, finance, and business development. Kathy enjoys traveling, spending time with her husband Mark as well as friends and family, cheering on the Chicago Cubs, and hanging out with her dog, Wrigley.
Nick has spent his entire career in Healthcare and Life Sciences and joined Catalyst as CEO in October 2018. After earning a bachelor’s degree in London, UK in 1992, he completed a three-year postgraduate program with the National Health Service (NHS) working in various healthcare and healthcare management settings. From there, Nick went on to lead the Support Services Finance Group for a large hospital in the southern part of England. For the past 21 years, he has worked in the clinical research space with Quintiles (IQVIA) and PPD Development leading Clinical Operations, Finance, IT, and Sales/Marketing functions. In 2011, he joined Novella Clinical as Chief Commercial Officer, and in 2016, he was appointed President. While there, he fervently embraced the need for therapeutically-focused CRO solutions interlaced with a flexible small biotech customer service model. Nick is passionate about soccer (aka football in his native England) and played for club, regional, school, and university teams. He has passed down that love of football to his two sons, Eric and Harrison, and spends significant time coaching and watching them play. Nick also loves to cook, watch movies and read.
Global Head Business Operations
Since 1992, Jeannie has played a significant role in the evolution of resourcing and alternative solutions for outsourcing clinical development programs. As a business development team member at a large multinational CRO, she became increasingly aware of the deficit between product pipeline demands and access to the right expertise to bring new products to market. In 1995, she co-founded The Woolf Group as a means of increasing the industry’s talent pool and providing a “just in time” cost-effective approach to product development and outsourcing strategies. Realizing that the use of technology would be a catalyst to drive the industry forward, she joined forces with Novella Clinical Inc., a full-service eCRO, and created Novella Clinical Resourcing, a resourcing division specializing in building geographic and therapeutically-aligned teams to support global product development. Noting a service delivery chasm between traditional staffing companies and full-service CROs, Jeannie returned to her entrepreneurial roots and co-founded Catalyst Clinical Research. Under her tutelage, Catalyst is filling that gap with flexible, cost-effective clinical service solutions for development companies who often get lost among the larger service providers. When she isn’t building something for Catalyst, Jeannie is passionate about helping to eradicate cancer from the planet. She enjoys playing with her dogs Sadie and Lily, taking long walks on the beach, and exploring the world with her husband, Dennis.
Global Head, Statistics and Programming
A co-founder of Triangle Biostatistics, Jeff brings 21 years of experience across multiple clinical research functions including data management, medical writing, clinical compliance, regulatory affairs, sales, and marketing to our biopharmaceutical industry clients. His expertise includes protocol development, study design, sample size determination, and generation of randomization schedules. He has also authored statistical analysis plans for numerous indications and interacted with regulatory agencies worldwide while shepherding regulatory submissions to gain marketing authorization for various compounds. When he’s not working with his colleagues at Catalyst, Jeff enjoys training in Brazilian Jiu-Jitsu and spending time with his wife, Kym, and their son, Jake.
Charles Wakeford, PhD
Chuck is a co-founder of Triangle Biostatistics and has provided statistical leadership in every phase of product development during his 29 years in the biopharmaceutical industry. Throughout his career, Chuck has worked with personnel in clinical research, data management, medical writing, clinical compliance, regulatory affairs, sales, and marketing. His expertise includes protocol development, study design, sample size determination, and generation of randomization schedules. He has also stewarded multiple regulatory submissions in collaboration with regulatory agencies worldwide. Chuck enjoys spending time with his family and dogs. He supports foundations and schools for people with developmental disabilities, plays multiple sports, and enjoys playing and recording music.
Global Head Clinical Operations, Strategic Resourcing
Betsy has dedicated her entire career to clinical research and serves today as an industry leader, resourcing expert, and business entrepreneur. She first joined the industry in 1985 working with FHI 360 in Women’s Health and HIV research. In 1987, she joined ClinTrials Research, a commercial spin-off of FHI 360 and one of the earliest international Clinical Research Organizations. As Associate Director, she managed a staff of CRA Managers and more than 100 CRAs. In 1995, Betsy co-founded and lead The Woolf Group, one of the earliest and most recognized clinical research staffing firms in the country. She helped develop the company into a premier service organization, highly sought-after by its clientele and candidates alike. The company was sold to an international staffing firm in 1999, and in 2002 she co-founded Trio Clinical Research. As the company’s Chief Operating Officer and then President, Betsy led the operations and business development team, ensuring the company’s growth and development, and drove a successful merger with Aptiv Solutions in 2008. In 2013, Betsy returned to her entrepreneurial roots and co-founded Catalyst Clinical Research, a niche clinical operations service provider. She continues in her leadership role with the company as the Global Head of Operations for Strategic Resourcing. Outside of work, Betsy enjoys spending time with her two boys, Hunter and Sam. They love to ski, snowboard, and travel with extended family and cousins. Sam’s best friend and labradoodle, Bella, enjoys hanging out at the office with Jeannie’s pup, Lily.
Chief Medical Officer, Medical and Safety Head
Lisa is our CMO and leads Medical and Safety at Catalyst Clinical Research. Board-certified in internal medicine, Lisa was in private medical practice for seven years before joining the industry as a medical director at a major CRO. She advanced to managing the global medical monitoring group and subsequently led multiple business units including Pharmacovigilance and Medical, Medical Communications, and Early Development. Lisa earned a Bachelor of Science degree in Chemistry from Texas A&M at Kingsville and a Doctor of Medicine degree from the University of Nebraska College of Medicine. She completed an internal medicine residency at the University of Arizona. Lisa enjoys paddle boarding, snowboarding, guitar, and working in the garden as she believes there is a farmer in all of us.
Data Management Head
Shelley heads Catalyst’s Data Management group and joins the team with over 25 years of industry experience working with large and small CROs, biotechnology companies, and research institutions. Her primary expertise is data management with a focus on technology, program directorships, client relationships, and business development. As a data management leader, Shelley co-founded one of the first companies to embrace EDC technology. She has developed data management departments and teams; driven technology analysis, decisions, and platform integrations; and taught Advanced Data Management courses at Campbell University School of Pharmacy in the Department of Clinical Research. As the head of Global Clinical Research Programs, Shelley played vital roles in a 22-study data management program, a global integrated endpoint adjudication program, and multiple large Phase III studies. While serving in a business development capacity, she applied proven relationship development principles and her operational and marketing solutions knowhow to convert strategic alliances and sales-focused activities into highly profitable marketplace operations. The impact on quality and results was immediate. She holds a bachelor’s degree in Communications and Marketing from the University of Arkansas at Little Rock. Shelley is an oenophile who enjoys spending time with family and friends, watching movies, and having fun in the sun. Having lost her own father to cancer, she’s committed to assisting companies in eliminating cancer from this world.
Global Head, Biometrics FSP Solutions
Chan leads our Biometrics FSP (Functional Service Provider) Solutions group at Catalyst. A co-founder of Triangle Biostatistics, he brings over 22 years of experience in the industry as a SAS® Programmer and has successfully managed programming groups at CROs and biopharmaceutical companies. Chan has led the work of an applications development group at a large biotech company where he developed SAS® macros to support regulatory submissions and other customized non-SAS® utilities. The clinical development program regulatory submissions he’s worked on have spanned multiple indications and programming environments. Chan enjoys playing golf, traveling with family and friends, and watching sports, especially when it’s his children playing soccer and basketball. He enjoys cooking and spending time at home with his wife, Michelle, and children, Katie and Cole.
The Right Solution for Your Situation
Small to mid-size biopharma customers require flexible, tailored solutions to operationalize their development programs. The solution for one study may not be appropriate for the next as each program has a unique time and place of its own. In fact, a one size fits all solution is no solution at all. To help advise you appropriately, we ask questions to assess your current situation including:
- Do you have the infrastructure (i.e., SOPs, systems) to support some or all of the study requirements?
- Are there internal resources for operational oversight?
- Do you have established site relationships?
- Do you have a development partner?
- What level of control is desirable (insourcing vs. outsourcing approach)?
- Do you utilize other functional partners in your outsourcing strategy?
- What is your risk tolerance?
- What are your budget considerations?
- What are your reporting requirements to the Board of Directors, shareholders, key conference presentations or white papers?
Based on our discussion, we deliver a truly customer/study-driven approach by tailoring a solution to best fit your study’s purpose and requirements. Catalyst can deliver solutions under three main scenarios with the flexibility to mix and match as desired.
Strategic Resourcing Solutions
Hand-picked seasoned professionals to augment your internal teams. Although individuals or teams are usually engaged for a single study, they can be deployed across protocols to gain efficiencies in clinical operations, biometrics and safety/medical functions. Catalyst strives to ensure therapeutic alignment and can provide one resource or an entire team internationally in 30 countries (to date) across North America, Europe, and LatAm.
Consider leveraging Catalyst’s broad network of experienced professionals when:
- You are internalizing a study and not outsourcing it to a CRO.
- Resourcing peaks run high, and there are just not enough internal capabilities to address the workload.
- You need to fill a talent gap with the right expertise at the desired time in a specific geography.
- You want to maintain control of the study’s quality, timing, and budget.
- Your relationships with investigative sites are of critical importance, and not just any CRA will do.
There are numerous advantages to engaging Catalyst’s Strategic Resourcing solutions, for starters:
- We work with only the most experienced industry professionals who apply their skills and knowledge to your program from day one. Our staff average 10-15 years of experience.
- With a project completion rate of 83%, you can rest assured there will be program continuity, especially among your study centers.
- Scalability to size up or down as your study dictates.
- Our staff serves as an extension of your team — your ambassadors to external partners, your KOLs and study centers.
- Less expensive service option than traditional outsourcing models.
Functional Service Provider (FSP) means different things to different service providers and clients because there is no one solution. Whether you need a part-time or fully dedicated team, Catalyst’s Workforce Solutions are customized to maximize efficiency in outsourcing without compromising quality and typically include performance management measures and governance framework. We build customized solutions for our clients within the following functional areas while respecting and integrating each unique culture to ensure fit.
- Clinical Operations
- Clinical Monitoring
- Program Management
- Centralized Monitoring
- Study Start-up
- CRO oversight and performance management under ICH E6 R2
- SAS Programming
- Data Standards and CDISC
- Data Management
- Clinical Programming
- Applications Development and Maintenance
- Medical & Safety
- Pharmacovigilance case processing and safety surveillance
- Medical Monitoring
Consider tapping into Catalyst’s highly experienced Workforce Solutions when:
- You can’t add internal headcount, yet there is an endless stream of work to do.
- You need to deploy dedicated or part-time functional resources across studies, programs, or even across business or therapeutic units to gain efficiencies.
- There are investments in legacy systems or SOPs that connect with different areas of the organization which must be maintained.
- Your organization seeks to comply with ICH E6R2, but you don’t have the internal resources to oversee your CRO partners.
The advantages when you engage Catalyst’s FSP Solutions include:
- Highly experienced staff: Our people average 10+ years of experience.
- Organically grown network: Work with a consistent team that understands your systems, your processes, and your expectations.
- Maximize your investment by utilizing your legacy systems and SOPs or ours.
- Flexibility & scalability: Our FSP model provides an easy and flexible way to scale up and avoid the expense of underutilized resources or full-time headcount.
- Industry-leading expertise: Benefit from the knowledge and experience of our industry-leading experts in clinical operations, biometrics, and product safety.
- Line and relationship management to ensure resourcing to forecast; quality, timelines, and performance management by metrics.
- Open communication: Strategic resourcing to long-term planning results in faster turnaround times and ensures resourcing is in place when needed.
- Cultural fit: We seek to partner with companies that are a good “fit.” Strong relationships are critical to making FSP programs successful.
Managed Studies Solutions:
a full-service solution focused on oncology therapeutics
Oncology clinical research is increasingly complex and dynamic. To be successful, it requires flexible and creative outsourcing solutions. For many reasons, some of them personal, the Catalyst team focuses our resources, time, and passion on being exceptional in the oncology clinical research space instead of being average in multi-therapeutic specialties.
We started with a blank whiteboard and have built our Managed Studies Solutions by specifically focusing investments in ways that make a difference when operationalizing oncology programs:
- Our leadership team has strong oncology and operational expertise, including specific, recent experience in immuno-oncology, cell and gene therapies, oncolytic viruses and other emerging scientific areas of research.
- Our systems interconnect and readily accept data from oncology trials.
- We have established site relationships and networks to ensure patient enrollment.
- We have developed third-party strategic partnerships with companies that offer a best in class solution for oncology-related clinical research services (i.e., concierge services, in-home patient visits, labs, imaging and diagnostic partners)
Catalyst’s Managed Study Solutions are best utilized when:
- You lack the internal infrastructure or support the study needs.
- Study implementation requires a fully managed approach including oversight of quality, budget, and timeline deliverables.
- The pre-requisite functional, therapeutic, or operational staff aren’t all available.
- You want to transfer regulatory obligations contractually.
The advantages to Catalyst’s Managed Studies Solutions include:
- Our focus is your benefit: Small to medium size clients desire a hands-on, collaborative, communicative approach. You won’t get lost with Catalyst.
- Phase-appropriate solutions. No cookie cutter approaches here.
- Oncology-focused operational teams and expertise to ensure a successful outcome including seasoned oncology monitors who average 12-15 years of experience and are regionally located near assigned study centers
- Flexibility to use your desired EDC vendor for data continuity or one of our preferred platforms
- Our oncology-oriented systems are leading edge and able to interconnect thereby reducing errors and eliminating redundancy.
SERVICES FOR CANDIDATES
What Our Candidates Say
“Catalyst is a superb resourcing agency to work with! As a 26-year independent Sr. CRA, I have contracted with Catalyst for the past several years. I have valued their consideration of my extensive oncology background and available time in providing consistent employment for me on a variety of great projects.”
“The Catalyst staff is always friendly, knowledgeable, and professional and responds quickly to all questions and issues. I have worked with many other CRAs and project managers placed by Catalyst, and they all are very seasoned, knowledgeable individuals with a team attitude.”
Let’s face it, today clinical research professionals have many choices when it comes to their next career move or contract opportunity. So why should you consider working with us?
Go with the best to be seen as the best.
Simply stated, we are the best at what we do. It’s true. Just ask our clients and other clinical professionals, many of whom we’ve continued to work with for more than two decades. It’s a prudent career move to associate with excellence and integrity.
Proven at opening doors and advancing careers.
Chances are we’ve either worked with you or someone you know. That’s how long we’ve been around. And we bring opportunities directly to you so you don’t have to spend non-billable time hunting down your next project. That’s a huge time saver and a great deal of relief.
We’re your advocate.
We are only as good as the people who work with us, so we greatly value each clinical professional who joins our team as we would a client. And contrary to some, you’re not a commodity to us—you’re a highly skilled professional! As clinical research professionals ourselves, we understand the nuances and challenges of our work. So we not only help ensure the next opportunity is just right for you, we support you every step of the way throughout the assignment.
We are very fortunate to have the opportunity to work with innovative clients with exciting new products that can make a difference in the lives of people throughout the world, from immunotherapies to vaccines. Isn’t that what it’s all about anyway? By joining Catalyst, you are automatically exposed to a variety of these Sponsor and CRO companies bringing a multitude of opportunities right to you.
Wide-ranging job opportunities.
We work hard every day to offer a variety of opportunities for both the seasoned and less experienced (two years plus) clinical professional, from CRAs to Program Managers to Medical Monitors. Whether direct hire or contract, check in and check often to view what’s on tap. And add us to your favorites!
View our Latest Job Openings
Ready to be a Catalyst?
Catalyst Clinical Research, LLC, U.S. Headquarters
5826 Fayetteville Rd Suite 202
Durham, NC 27713 USA
Catalyst Clinical Research Ltd., EU Office
266 Irby Road
Irby, Merseyside, CH61 2XQ
Get In Touch
Want to know how Catalyst can support your development programs using our Fit-for-Purpose model? Send us an email (email@example.com), or complete the form below and we’ll get back to you shortly.