- 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, Quality and Vendor Management
At Catalyst, John is responsible for vendor oversight and the quality management system. His clinical research career spans 20 years having work experience in a variety of clinical research organizations from small start-ups to a large global firm spanning roles and operational functions ranging from study startup, QA, medical writing, contracts and vendor management. As the quality champion for Catalyst, John has embraced the company’s people-first approach, believing quality begins with well-trained, motivated, and ethical employees who approach every client project with urgency and care.
John and his wife Allison try to live by three simple rules – work hard, play hard, and Die Hard (the Christmas movie). John strives to keep pace with his ambitious young adult daughters, Maggie and Rosie, while also meeting the exercise and affection demands of his Poodle-Aussie mixes, Otis and Oscar. Now living amongst the fan bases of the Tar Heels, Blue Devils, and Wolfpack, John remains an ardent supporter of his alma mater, the Virginia Cavaliers. Wahoo!
Patti has over 24 years of finance experience, 20 of which is in the clinical research industry. She has a diverse background in financial leadership and a passion for team engagement and talent management. Patti started her professional career as a tax consultant at Deloitte & Touche LLP, then moved into the healthcare field in a senior finance role at NES, an emergency room staffing and management company. She got her start in the clinical research industry in 2000 at PPD. During her tenure at PPD she held a variety of roles, including several roles in tax, operations finance leadership, and most recently ownership of the government business unit. While at PPD she played an important part in the significant growth of the company, both related to adding service offerings and expanding internationally. She led the globalization of finances for the clinical development business unit and partnered with business unit leadership to optimize revenue and profitability. In addition to her industry experience, Patti has also taught accounting classes at San Diego State University and North Carolina Wesleyan University. Outside of work Patti enjoys being outside with family and friends – first choice is beach and traveling, followed closely by anything active – volleyball, walking, pool, playing with her two yellow lab mutts. Ideally with a cool beverage in hand of course!
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.
Ron van Eijsden
Managing Director, European Head
Ron brings a broad commercial experience in Life Sciences to Catalyst covering (Clinical) Development, Medical Devices, Quality and Clinical Research. From origin Ron is a biologist and he holds a PhD in molecular biology. After working as a Post-Doc on the development of alternative antibiotics for some years, Ron left university life and entered Life Sciences industry. Over the last 20+ years Ron has been involved in development and the clinical research industry. As a country – and later as a European Director, he managed the operations of 12 different European countries (including business development, managing all clinical resourcing activities, establishing new local affiliates and managing some clinical teams in an FSP model). In parallel, Ron has worked as a consultant for a couple of years, supporting small – and mid-sized biotech clients that were active within R&D and Clinical Development. Over the last couple of years and prior to joining Catalyst as a Managing Director/Head of European Operation, Ron was the managing director of the European division of an oncology specialized US based CRO. Ron and his family live in the “Duin & Bollenstreek” in the Netherlands, located in the middle of the beautifully colored fields of tulips, crocuses and hyacinths that bloom in Spring. He’s a real family man and in his private life Ron loves to spend time working in his garden, fishing and having prime-time with his kids and granddaughter during family BBQ’s.
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.
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.
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.
Global Head Oncology Strategy and Science
Joe is an industry veteran with more than 23 years in clinical research with biotech, pharmaceutical and CRO companies. At Catalyst, he is our Global Head of Oncology Strategy and Science. With broad experience spanning both hematology and solid tumor oncology portfolios, Joe’s strategic perspective to flexible operational delivery drives customized solutions which address challenges throughout the product development process and life cycle. Joe continues to establish and develop successful partnerships with research sites, site networks, specialized clinical research vendors, and project teams across a wide range of protocol design models, oncology indications, and geographic regions. Joe’s leadership has helped advance numerous oncology assets through the rigorous approval pathway and assisted with increased clinical trial access to patients with cancer. Joe is based in the Kansas City (on the Missouri side) metro area, but is an Iowa farm boy at heart. Outside of his role here at Catalyst, Joe spends a good portion of his time on home remodeling projects, furniture building/refinishing, working on his pottery skills, anything paranormal-related, and concocting a good craft cocktail on occasion.
Global Head, Data Management
Shannon comes to Catalyst as an industry veteran focused in data management and programming technologies spanning over 25 years. She has worked for both global biopharmaceutical companies as well as with large and small clinical research organizations. Shannon has extensive project management experience with biometrics studies, encompassing Phase I through IV programs across therapeutic areas. Over her career, she has managed multiple, high-volume, complex clinical trials focused on technologies and building client relationships. She has broad expertise in CDM platforms and e-clinical solutions and has successfully participated in the implementation and validation of various systems. Shannon holds a Master of Science in Business Management degree and her goal is to provide clients with strategic expertise to facilitate data collection, review, and reporting while ensuring that data are of high integrity for critical decision pathways. Outside of work, Shannon loves traveling, spending time with family and friends and cheering on her two sons in their various sporting activities.
PMP, Global Head,
Project Management and Clinical Operations
Keya Watkins joins Catalyst as the Global Head of Project Management and Clinical Operations. In this capacity she is responsible for the quality and delivery of the clinical trial portfolio within the Catalyst CRO full services business unit.
Throughout her 22-year career in clinical research with both biopharma and clinical service providers, Keya has provided oversight of multidisciplinary teams in project management, clinical monitoring and site support services. She also served as an executive in both operational and commercial roles and has been involved in several complex, global trials in various therapeutic areas and phases with a concentration on hematology and oncology programs . Keya prides herself on building and managing high-functioning teams that deliver excellence while ultimately bringing meaningful therapies to patients in need. Previously, she served as vice president of clinical operations at Clinipace, senior vice president of clinical services at WIRB-Copernicus Group, senior vice president at ePharmaSolutions and executive vice president of clinical development at Omnicare Clinical Research. When she isn’t supporting customers in curing cancer, Keya enjoys spending time with her husband and 2 teenage sons and taking long rides with her husband on their Harley motorcycles.
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 (firstname.lastname@example.org), or complete the form below and we’ll get back to you shortly.