At Study Source One, our mission is to empower clinical researchers by alleviating administrative burdens and providing consultation services and support, allowing them to concentrate on what matters most:
safeguarding their subjects and ensuring high-quality data.
We recognize the complexities that clinical researchers face in the timely and costly creation of source and SOPs. Drawing on over 25 years of industry experience, our founder identified a critical need for a more efficient, streamlined approach to mitigate the time-consuming and challenging process of re-creating source study after study. In response to this challenge, Study Source One is committed to transforming the operational framework of clinical research, driving greater efficiency and productivity for the research site, whose primary focus should be subject safety and quality data.
Beyond our comprehensive document solutions, we offer specialized consulting services designed to address the unique challenges of clinical research. Our tailored approach ensures that our offerings are aligned with the needs suited to your individual site. Whether you need research questions or concerns addressed, training sessions, an assessment of your site processes to improve efficiency and ensure regulatory compliance, we are here to assist and support you.
Melanie Gibb has a vast amount of experience working in the Clinical Research Industry for 23 years as a Coordinator (7 yrs), Coordinator Manager (1 yr) and Site Director (15 yrs). Her career experience includes conducting, directing, and overseeing more than 200 phase I-IV clinical trials, throughout a broad spectrum of multi-specialty therapeutic indications from infants to seniors. Melanie is well versed with the Code of Federal Regulations Title 21 Part 312, all versions of ICH E6 Guidelines, FDA Guidance Documents, IRB’s policies and procedures, and Regulatory requirements. As a Site Director, she built a highly successful research department from the ground-up at a multi-specialty clinic with more than 150 Providers. One of her passions is helping others, which includes training and mentoring researchers because the work they do is so important to our global community.
Cheryl Ritchie, RN,BSN, has been actively involved in the pharmaceutical and medical device clinical research industry for over 40 years. During the course of her career, she has co-founded five medical research companies, Medical Research Associates of Utah, Inc., Institute for Neuroscience Research, Inc., Brain Injury Research Strategies, Inc., (winner of the 2015 USC Viterbi School of Engineering Maseeh Entrepreneurship Grand Prize Award) Human Performance, Inc. and Reaction Speed Sports, Inc., leading these companies through her positions as Founder/Owner, Vice President, Chief Operations Officer and Chief Financial Officer. She is the owner of Cheryl Ritchie, LLC, a clinical operations consulting company.
Ms. Ritchie has served on the University of Utah College of Nursing Development Advisory Board, the APSARD Membership Committee, the Act of Love Charitable Fundraising Committee, the University of Utah Medical Center Foundation Fundraising Committee and the Advisory Board for MoodDoctor.
Shawn Larsen is a Senior Clinical Research Coordinator with extensive experience managing all phases of clinical trials, from study start-up to close-out. With in-depth knowledge of Good Clinical Practice (GCP) and FDA regulations, he ensures studies are conducted with precision and strict compliance. A key aspect of his role is developing and managing accurate source documents, essential for maintaining data integrity and meeting regulatory requirements. His meticulous attention to detail and strong organizational skills support the seamless creation of comprehensive, compliant documentation throughout the trial lifecycle. In addition to overseeing daily trial operations, Shawn collaborates closely with cross-functional teams to drive study success. His expertise in source documentation and regulatory compliance makes him an invaluable asset to clinical research projects.
Sheila Estepan is a strategic Executive Operations Leader with 20+ years of experience supporting C-suite executives across nonprofit, government, and academia. She specializes in executive operations, organizational strategy, and stakeholder engagement, ensuring seamless leadership support and operational efficiency. Sheila has held key roles at the National Network of Abortion Funds, Groundswell Fund, Columbia University, Girl Scouts of the USA, and the NYC Mayor’s Office, driving cross-functional initiatives and strategic partnerships. Known for streamlining executive priorities and overseeing high-impact projects, she brings a solutions-oriented approach to leadership. Sheila holds a B.A. in Psychology from Hunter College.
Rachelle Vertenten is a seasoned professional in change management, negotiation, and conflict resolution. With experience spanning Dell Technologies, IBM, and Columbia University, she has led large-scale organizational transformations and cultivated high-performance cultures.
Holding an MSc in Negotiation and Conflict Resolution from Columbia University, Ms. Vertenten has conducted research in the fields of communication theory and the unique dynamics of tech start-ups. Her global work includes peacebuilding initiatives, notably developing a culturally inclusive conflict transformation framework for CECORE in Uganda.
Wynne Chan is an accomplished product leader with over a decade of experience driving innovation at the intersection of design and technology. Most recently, she has served as Head of Product at Kumospace, leading product strategy and development for immersive virtual collaboration tools. Prior to that, she played a pivotal role as Paperless Post’s VP of Product Design, shaping the platform’s user experience and design vision. With deep expertise in product strategy, user-centered design, and team leadership, she is passionate about building intuitive digital experiences that engage and delight users.
Prudence Harms is a results-driven HR leader with experience across Manufacturing, Retail, and Distribution. She excels at driving performance, motivating teams, and building high-performing workforces across multiple locations. With a proven track record in merging HR practices during acquisitions, Prudence ensures smooth transitions and long-term success. Her expertise includes talent acquisition, succession planning, organizational development, change management, training, HR policy, HRSS systems, and compensation. A passionate advocate for Diversity, Equity, and Inclusion, Prudence fosters inclusive, high-performing cultures. At Study Source One, her commitment to positive employer-employee relations and legal compliance drives continuous improvement, ensuring a thriving workplace environment.
Charlese Porter is a results-driven professional who excels in forging strategic relationships, facilitating growth initiatives, and fostering cross-functional collaboration. With a Bachelor of Science in Business Management from Hampton University and certifications from CSU Global and IBM, she leverages diverse experiences in Human Resources, marketing, and customer service to drive business success. From identifying key industry events to implementing growth strategies and expanding market presence, she applies a resourceful, data-informed approach. In her role as Business Development Manager, she focuses on cultivating meaningful partnerships and delivering innovative solutions for sustainable success.
Contact us today to learn more about how our services can benefit your site, assist you with challenges, and alleviate your research burdens