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CRF Bracket offers a unique suite of solutions, with a unique perspective on clinical research development. We focus on bringing together best-in-class science, technology and service to drive superior clinical outcome results for our clients and for their patients.
CRF Bracket was created in 2011 through the merger of the Specialty Clinical Services and Clinical Technologies Group business units within United BioSource Corporation (UBC). CRF Bracket is no longer owned by UBC and is an independent business.
CRF Bracket, with nine offices and more than 700 employees worldwide, is a clinical trial technology and specialty services provider dedicated to helping biopharmaceutical sponsors and contract research organizations increase the power of their clinical research data by leveraging core competencies in Science, Technology, and Service.
Mike Nolte joined in 2018 as the Chief Executive Officer. Mike is a seasoned operational leader whose career spans the healthcare, technology and financial services industries. Mike recently serving as Chief Executive Officer at Influence Health. Prior to that position, Mike served as President, Chief Operating Officer and Director of the public company MedAssets (MDAS), prior to which he spent 7 years at General Electric (GE), including roles as Vice President and General Manager of Americas Services for GE’s Healthcare IT business, where he led more than 1,700 teammates focused on GE’s $900 million healthcare software portfolio, VP and GM of GE’s $230 million enterprise revenue cycle software business and VP and GM of marketing and product management for GE Healthcare IT’s ambulatory segment. He also spent five years with McKinsey & Company and started his career as a U.S. Army Officer, finishing up as a Captain and Company Commander for an airborne, rapid deployment, medical supply chain and maintenance organization. Mike holds a Master of Business Administration from The University of Chicago Booth School of Business and a Bachelor’s Degree from the University of Notre Dame.
Mitch Blumenfeld oversees Finance, Quality and all Legal and Regulatory Affairs. He joined from PCI Pharma Services, the world’s largest provider of outsourced pharmaceutical packaging and related services where he was responsible for all financial management for 18 facilities across North America, Europe and Australia. He led PCI’s finance functions during a period of rapid growth, including a ten-fold increase in EBITDA and the successful completion of five acquisitions in the US, UK, Ireland and Australia. Prior to his time with PCI, Mitch worked for AmerisourceBergen as the Senior Vice President and CFO of the Drug Corporation and led the integration and finance functions for World Courier, the world leader in global cold chain and clinical trial logistics with offices in over 140 countries. Mitch started work with GE, having a career spanning 15 years and roles in the US and Europe with the Appliances, Lighting, Information Services and Water Technology businesses as well as five years in the Corporate Audit Staff. He is a graduate of GE’s Edison Engineering Program and Advanced Courses in Engineering. Mitch holds a Bachelor of Science in Computer Science Engineering from Bucknell University and a Master of Science in Computer Science & Applications from Virginia Tech.
Christopher L. Crucitti, MS, leads the commercial functions of the organization, as well as the go-to-market strategy, to drive the continued growth of our already market-leading clinical technology solutions platform. Chris brings significant experience and expertise in the clinical and R&D domains. He has led organizations to significant revenue and profitability growth, while maintaining a high level of customer service and quality delivery. He joined from Science Exchange, having served as Chief Commercial Officer for the world’s largest enterprise platform to manage outsourced R&D services. Prior to Science Exchange, he held various senior executive-level positions and oversight of commercial functions within the CRO industry (most notably Worldwide Clinical Trials and inVentiv Health Clinical) overseeing solutions spanning technology, consulting, strategic resourcing, clinical development and R&D. Chris holds a Master of Science from American University and a Bachelor of Science from Ithaca College.
Sarah Dixon oversees human resources for over 1,500 employees worldwide. She has held numerous positions in the Human Resources Management area for over 24 years. Sarah began her career in retail management both in the store and in Head Office roles. She then moved into the Life Sciences sector, initially working for GlaxoWellcome (becoming GSK) with their Global IT group and spending a considerable amount of time in the US. Since then Sarah has had the opportunity to work for a number of organizations in Life Sciences and Biotech in North America, Europe and Japan including Vernalis, CMR International, and Otsuka Pharmaceutical Europe. Sarah holds a Bachelor of Arts (Honors) in Business Studies and is a Fellow of the Chartered Institute of Personnel and Development.
Risto Enbuska leads the engineering functions for CRF Health legacy solutions. He has over 20 years of experience in Research and Development for mobile networks and devices. He started his professional career at Nokia Finland in 1993 as a software development engineer but soon progressed to a management position. He worked for extended periods first in the US and then in Hungary while ramping up and running R&D centers. Risto has a proven track record in large scale R&D function management and organizational leadership in a global environment. He has extensive experience in high quality software development including both quality control and SW development systems. R&D renewal has always been on his agenda and he has successfully implemented agile/scrum transitions. Prior to joining CRF Health Risto worked in R&D leadership positions at Nokia, Tellabs and Comptel. Risto holds a Bachelor of Science in Telecommunications.
James Jay oversees the global service business. He has 18 years of experience building successful software solutions for healthcare and life sciences. For the preceding six years he led the Global Imaging IT business at Agfa HealthCare, where he transformed the business strategy while creating a new market segment and established early market leadership. Prior to Agfa, James spent 13 years at GE, where he led the Global Cardiology IT business and held other roles across R&D and program management. James has an Master of Business Administration in Global Management from American Intercontinental University and a Bachelor of Science in Computer Science from the University of Oregon.
Jim Primerano oversees the delivery of the eClinical solutions portfolio. Jim has 20 years of clinical research and technology experience, leading teams to bring innovative solutions to the pharmaceutical industry in support of clinical development. Prior to joining, Jim was Sr. Director of Product Strategy with Medidata Solutions, where he was responsible for driving product portfolio expansion. Jim holds a Bachelor of Arts in Biology from the University of Pennsylvania and a Master of Business Administration in Global Business from Rider University.
Rauha Tulkki-Wilke leads cross-functional design and development of eCOA solutions for client and therapeutic area needs, combining science and patient experience with leading technology. Rauha has close to 20 years of experience with all that eCOA encompasses and has a genuine interest in digital health. Prior to moving to the pharmaceutical industry, she developed solutions for anesthesia management and neonatal intensive care. Rauha holds a Master of Science in Biophysics and Biomedical Engineering.
Dr. David Daniel provides overall scientific, clinical and strategic direction for our solutions. Dr. Daniel was the founder and President of Global Learning, LLC which was acquired by United BioSource Corporation in July 2006. He formerly served as Medical Director of the NIMH Neuroscience Center at Saint Elizabeth’s, Director of Clinical Trials for the Stanley Foundation and was a founding Principal of Best Practice, LLC. For over 30 years, Dr. Daniel has supervised and trained raters in psychiatric clinical trials globally. He has published numerous scientific articles involving clinical trials and investigations of the psychopathology of mental illness. He has received patent protection for new treatment approaches in epilepsy, anxiety disorders and psychotic disorders. Dr. Daniel graduated Phi Beta Kappa and Magna Cum Laude from Emory University and obtained his medical school and psychiatry post-graduate training at Vanderbilt University, where he served as chief resident. He was a medical staff fellow and senior staff fellow within the intramural program of the National Institute of Mental Health (DIRP, NIMH) for five years.
Michelle Ronan is responsible for strategic initiatives, including mergers and acquisitions, strategic partnerships, market analysis and pricing strategy. Prior to joining, Michelle was Director of M&A Life Sciences at a large international accountancy firm. She worked across all areas of corporate finance and has significant experience in advising companies across all facets of a transaction, including working with both private equity and trade investors, raising debt finance, deal structuring and business valuations. Michelle is a member of the Institute of Chartered Accountants in England and Wales and holds a Bachelor of Arts (Honors) from University College London.
Bill Byrom, PhD, leads product strategy and innovation. He has worked in the pharmaceutical industry for over 25 years in various positions within clinical development within pharmaceutical companies including Boots, Knoll and Zeneca. Bill has served as a product strategy leader within eClinical technology companies and CROs including ClinPhone, PAREXEL Informatics and ICON. He is the author of over 70 publications, including two industry textbooks on electronic patient-reported outcomes (ePRO). His recent scientific work includes consensus guidelines on the implementation of wearable and mobile sensor technology in clinical trials, and scientific validation supporting the use of bring-your-own-device ePRO in clinical trials. Bill has served two years as Vice Director of the Critical Path Institute’s ePRO Consortium and is an active member of the Drug Information Association as an Annual Meeting Steering group member and within the Study Endpoints Community. Bill is visiting senior research fellow at Nottingham Trent University’s Medical Design Research group. Bill holds a Doctor of Philosophy (PhD) in Mathematical Modelling and Simulation from the University of Strathclyde and a Bachelor of Science from the University of Nottingham.
Nicole Kerr leads product management focused on the strategy, development and execution of the roadmap for the entire product portfolio. She has worked in product for over 10 years and has significant experience in technology product management, product strategy and go-to-market activities assisting in the growth and adoption of products. Prior to joining, Nicole was the Vice President of Product Management at Monetate, where she drove the full-life cycle product management for Monetate’s products. She was the primary driver of the product vision, defined the product strategy, oversaw the prioritization and development of products and delivery of those solutions to clients. Nicole holds a Master of Business Administration from Saint Joseph’s University’s Haub School of Business and a Bachelor of Science in Management and Marketing from Ithaca College.
Luke Embree handles the engineering functions for Bracket legacy solutions. Luke’s diverse professional background and strategic vision have facilitated his smooth transition into an engineering leadership role. In addition to his impressive technical abilities, Luke is an experienced budgeter, innovative problem solver, and a capable manager. Prior to joining, Luke served as the VP of Technology at FamilyWize Community Service Partnership, the Director of Core Development at Pet360 and the CTO at Idayo Investor, Inc. Luke’s deep-rooted competitive drive is evident, as he is constantly working to improve his performance and the performance of his colleagues. Luke holds a Bachelor’s degree in Computer Science from Shippensburg University of Pennsylvania.
Thomas is responsible for all of CRF Bracket’s Quality Management oversight. Thomas has over 20 years of Quality Management experience. Prior to CRF Bracket, he was Manager Quality Services for Clarix LLC and Quatern, LLC and the Audit Manager for Almac Clinical Technologies. Thomas holds a BS in Biology from Millersville University and has formalized training in Good Clinical Practices (GCP), Good Manufacturing Practices (GMP), 21 CFR 11, FDA, ICH and IEEE Validation Guidelines, HIPAA, CAPA Management, Deviation / Incident Reporting and Project Management.
Dr. Daniel provides overall scientific, clinical and strategic direction for Bracket’s services. Dr. Daniel was the founder and President of Global Learning, LLC which was acquired by United BioSource Corporation in July 2006. He formerly served as Medical Director of the NIMH Neuroscience Center at Saint Elizabeth’s, Director of Clinical Trials for the Stanley Foundation, and was a founding Principal of Best Practice, LLC. For over 20 years, Dr. Daniel has supervised and trained raters in psychiatric clinical trials in the US and globally. He has published numerous scientific articles involving clinical trials and investigations of the psychopathology of mental illness. He has received patent protection for new treatment approaches in epilepsy, anxiety disorders and psychotic disorders. Dr. Daniel graduated Phi Beta Kappa and Magna Cum Laude from Emory University and obtained his medical school and psychiatry post-graduate training at Vanderbilt University, where he served as chief resident. He was a medical staff fellow and senior staff fellow within the intramural program of the National Institute of Mental Health (DIRP, NIMH) for five years.
Dr. Targum consults widely to the pharmaceutical industry regarding the design and implementation of clinical trials for new psychotropic drugs and the progression of drug development from concept to approval to launch. In addition to his work at Bracket, Dr. Targum is a Chief Medical Advisor at Prana Biotechnology Ltd. and has served as Chief Medical Officer at several small biotechnology and pharmaceutical companies. In 1991, Dr. Targum established and operated a multi-site clinical trials program in Philadelphia. As Principal Investigator, he conducted over 200 clinical drug trials in therapeutic areas that included anxiety, depression, mania, schizophrenia, and Alzheimer’s disease. In 2001, Dr. Targum founded PharmaStar, a rater training and medical education company focused on CNS drug development and international clinical trials. The company grew quickly and became the global leader in this niche when it was sold in October 2004 to United BioSource Corporation. Previously, He was Professor of Psychiatry and Vice-Chairman of the Department of Mental Health Sciences at Hahnemann University School of Medicine (Philadelphia) from 1989-1995. He has published over 100 scientific articles in the areas of psychopharmacology, psychobiology, and clinical trials methodology. Dr. Targum has a B.A. in biology from Colgate University and an M.D. from Mount Sinai School of Medicine.
Dr. Busner has over 30 years of experience as an academic clinical psychiatric researcher. She has served as the Principal Investigator for 49 industry-sponsored psychiatric clinical trials and Sub-Investigator for 35 additional clinical trials. She has served continuously on University Institutional Review Boards (IRBs) for the 20 years that preceded her move to Bracket. Dr. Busner is an active contributor to the psychopharmacology literature and has authored or coauthored over 100 peer-reviewed articles and national or international scientific presentations. Prior to Bracket, Dr. Busner directed the psychiatric clinical trials units of two major medical schools. She serves as Bracket’s Expert Presenter and Scientific Lead for US and multinational studies of depressive disorders, anxiety disorders, attention deficit hyperactivity disorder and all child and adolescent psychiatric indications. She has trained thousands of psychiatric clinical trial investigators across the globe and lectures frequently on the application of objective rating scales in the assessment of diagnosis and efficacy in psychopharmacology, ethics in psychiatric research, the placebo effect in psychiatric research and techniques for its minimization, the role of IRBs and clinical trial methodology. Dr. Busner received her PhD in Experimental Social Psychology and her MA in General Psychology from Adelphi University. She is licensed to practice psychology in Pennsylvania, Missouri and New York.
As Clinical Vice President, Dr. Fredane will serve as the Therapeutic Area Leader for neurology and will oversee Bracket’s eCOA, Rater Training, and Quality Assurance work in this important therapeutic area. Prior to joining Bracket, Dr. Fredane served as a practicing neurologist and clinical assistant professor of Neurology at Drexel University College of Medicine in Philadelphia, Pennsylvania. He has worked in pharmaceutical drug development at several companies including at Sanofi/Genzyme Pharmaceuticals, Meda Pharmaceuticals and with CRO Omnicare Clinical Research. He also maintains extensive experience in medical affairs and has published research on multiple sclerosis, pain management and transplantation. Dr. Fredane received his medical degree from Albert Einstein College of Medicine and completed his training with a residency in Neurology at Duke University. He completed fellowships in Clinical Immunology at St. Luke’s-Roosevelt Hospital Center in New York and in Immunology at Yale University School of Medicine in New Haven, Connecticut through a research fellowship with the National MS Society.
Dr. Hamilton was President and Founder of DynaRand, LLC, a software company that pioneered the development of IVRS and IWRS solutions for clinical trials management. DynaRand was acquired by United BioSource Corporation in 2005. Since the inception of DynaRand in 1998, he has pioneered the use of IVRS for automated adaptive studies, especially in the area of dynamic randomization. Dr. Hamilton works closely with pharmaceutical companies regarding the statistical aspects of adaptive trials and randomization algorithms, in addition to monitoring the integrity of Bracket’s randomization processes. Previously, Dr. Hamilton held a role of Senior Biostatistician at Genentech, Inc. and is a NI-NINDS Grant Review Committee member. Widely published, he holds memberships in the American Statistical Association and the American Academy of Neurology and Biometrics. Dr. Hamilton received his undergraduate degree from the University of California at Davis in Economics and Rhetoric, his Master of Science from the University of California at Los Angeles in Biostatistics, and his PhD in Biostatistics from the University of North Carolina.
Dr. Kalali helps identify innovative technologies to support the evolution of Bracket’s growth. In addition, Dr. Kalali will assist in the acceleration of growth in Bracket’s CNS product lines in other fields of medicine. He is Professor of Psychiatry at University of California San Diego, Editor of the journal Innovations in Clinical Neuroscience, and the Lead Editor of the book Essential CNS Drug Development, published by Cambridge University Press. He has authored over 150 peer-reviewed publications. Recognized globally as a leader in drug development and healthcare with an emphasis on innovation, collaboration, and the intersection with new technology, Dr. Kalali was the Founding Chairman of the Executive Committee of the International Society for CNS Drug Development (ISCDD), a founding member of the International Society for CNS Clinical Trials and Methodology (ISCTM), where he serves on Executive Committee, the Scientific Committee, and previously chaired the Membership and Publication Committees. He is also a founder and Co- Chair of the Scientific Program Committee of the CNS Summit, and serves on the Scientific Program Committee of the American College of Neuropsychopharmacology. Dr. Kalali regularly presents at national and international scientific meetings, and lectures frequently on drug development, innovation, technology, digital medicine and health. He is an advisor to the Center for Digital Transformation at the Paul Merage School of Business at the University of California, Irvine. Dr. Kalali earned his medical degree from the University of London and completed his psychiatry training at University College and Middlesex School of Medicine, University of London.
Dr. Kott is based in Bracket’s Prague office and until recently was Senior Clinical Manager for Europe. Having led the development of the Data Analytics Program for Bracket, he has overseen the design and reporting of data analytics in multiple large schizophrenia studies. For the past seven years, he has also provided training to investigators as an Expert Trainer. Dr. Kott has been responsible for the design and implementation of multiple in-study data quality programs and served as a Product Business Owner for Rater Reliability Statistical Measures Application. Prior to Bracket, Dr. Kott worked as a house officer in Psychiatry at General Teaching Hospital, Department of Psychiatry, and as an Assistant Professor at Charles University, 1st Medical Faculty – Department of Psychiatry, in Prague. Dr. Kott has a Medicinae Universae Doctor (MUDr) from Charles University.
Dr. Miller has over 20 years of clinical, clinical research and teaching experience, primarily in the field of geriatric psychiatry. After completing his 2-year fellowship in geriatric psychiatry at the University of Pennsylvania, he joined the faculty and served as an Assistant Professor of Psychiatry. Dr. Miller then went on to the University of Medicine and Dentistry of New Jersey, where he served as an Associate Professor of Psychiatry. Prior to joining Bracket, Dr. Miller served as Chief of Geriatric Psychiatry, Medical Director of ECT, and President of the Medical Staff at Friends Hospital in Philadelphia, PA. At all of these institutions, he oversaw the education and training of medical students, residents and fellows in geriatric psychiatry, and was recognized with a departmental teaching award. Dr. Miller has served as a Principal Investigator in a number of dementia clinical trials. In addition, he has lectured locally, nationally and internationally on his dementia related research. Dr. Miller serves as the Co-Chair of the ISTAART funded Neuropsychiatric Syndromes in Dementia – Professional Interest Area (NPS-PIA), and as the Co-Chair of the ISCTM Working Group focusing on the same area. Additionally, Dr. Miller is a co-author on the updated ADCS ADAS-Cog administration and scoring manual. Since joining Bracket, Dr. Miller has consulted on multiple dementia protocols and has served as the Expert Presenter at dozens of investigators’ meetings across the globe, including those addressing behavioral abnormalities and agitation in the context of dementia.
Dr. Sachs is the Therapeutic Area Leader in bipolar disease and mood disorders at Bracket. He previously co-founded Concordant Rater Systems, a specialty provider of technologies to improve CNS clinical research. Dr. Sachs is a recognized expert clinical trialist with extensive experience in rater training and the methodologies of mood and anxiety disorder research. He has been instrumental in developing technology-based solutions for randomized controlled trials that identify correlates of high placebo response, improve signal detection and reduce the risk of failed trials. Dr. Sachs is the founder and director of the Bipolar Clinic and Research Program at Massachusetts General Hospital (MGH) and is an Associate Professor of Psychiatry at Harvard Medical School. After graduating from the University of Pennsylvania and the University of Maryland Medical School, he completed his residency at MGH. His areas of academic interest include psychopharmacology, chronobiology, bipolar mood disorder and development of pragmatic measure-based practice guidelines. Dr. Sachs is Chair of the National Alliance on Mental Illness Scientific Advisory Board and serves on the Scientific Advisory Board of the Depression and Bipolar Support Alliance. He has authored over 200 articles, abstracts, books and book chapters.
At Bracket, we share a sense of responsibility for the social and environmental success of our communities and the human health of our employees and patients worldwide. Supporting organizations that improve the wellbeing of our planet and people is integral to our business.
Our teams take pride in supporting local organizations by organizing and participating in volunteer-led events during regular work hours.
Organization: Reading Family Aid Event: Toys & Teens Appeal Date: December 2017 Location: Reading, UK
The Bracket UK staff volunteer to help sort toys for needy families to help them celebrate Christmas
Organization: Alzheimer’s Association Event: Walk to End Alzheimer’s Date: November 2017 Location: Philadelphia, PA
More than 40 Bracket employees raised money for the Alzheimer’s Association and participated in the walk. The company team won the Rookie of the Year Award for being the highest fundraising new team in 2017. Read More
Organization: National Alliance on Mental Illness (NAMI) of PA Montgomery County Event: 6th Annual Benefit for the Brain Date: November 2017 Location: West Conshohocken, PA
Bracket sponsored this event to support both medical and non-medical research and services for mental illness. Bracket team members attended to raise funds to educate, support and advocate for those living with mental illness. Read More
Organization: Macmillan Cancer Support Event: Breakfast & Coffee Fundraiser Date: September 2017 Location: Reading, UK
The Bracket UK staff volunteered to raise money in aid of the national World’s Biggest Coffee Morning held each year by the Macmillan Cancer Support charity.
Organization: Anti-Defamation League (ADL) Event: Walk Against Hate Date: May 2017 Location: Philadelphia, PA
Bracket employees participated in ADL’s 7th Annual WALK Against Hate to take part in a one-of-a-kind initiative in which people from various backgrounds are united to make strides toward embracing diversity. Read More
Organization: National MS Society Event: Walk MS Date: April 2017 Location: Phoenixville, PA
Bracket employees participated in the MS Walk and wore orange shirts walking the trail for awareness. Read More
Organization: American Cancer Society Event: Making Strides Against Breast Cancer Walk Date: 2016 & 2017 Location: Montgomery County, PA
For two years in a row, Bracket employees have walked to raise money for breast cancer research and to show support and solidarity for their fellow colleagues who are survivors. Read More (2016) Read More (2017)
Organization: Special Olympics PA Event: Fall Festival for Special Olympics Date: November 2016 Location: Villanova University
Bracket employees volunteered at the Fall Festival for Special Olympics located at Villanova University. Read More
Organization: MS Society Event: Bike MS, City to Shore Ride Date: 2011, 2012, 2013, 2014 Location: New Jersey
Four years in a row, Bracket employees participated in the MS Society’s City to Shore Ride, a 75 mile bike ride, to raise awareness for MS.
We strive to ensure our business practices have minimal impact on the environment. We are committed to implementing green business initiatives at our offices across the globe. Energy Conservation We purchase only Energy-Star certified office and computer equipment and only Energy-Star certified appliances and equipment are used in new construction projects. To reduce our energy usage in existing offices, we have installed blinds, light sensors, and compact fluorescent bulbs, which use about 75% less energy than standard bulbs. Waste Reduction Bracket provides employees with filtered-water coolers, reusable coffee mugs, and BPA free tumblers to reduce plastic and paper waste. Green-Friendly Facilities and Construction Many of our office buildings are Class A, LEED, or Energy Star certified. When constructing new offices, we work with industry professionals who help to design our offices with sustainability goals in mind. Bracket uses recycled building products and paint free of or containing low amounts of volatile organic compounds.