Proven leadership in cardiovascular and metabolic disease trials





About Integrium » Our Team

As experts with a reputation for excellence, Integrium has been able to attract and retain the best and the brightest in the clinical research and development field. Together with our founders, they bring valuable insight to every project, helping clients successfully navigate the complexities of each unique clinical trial.

Executive Team

David H. G. Smith, MD
Founding Partner, Chief Medical Officer

Adam Steadman
Chief Strategy Officer

Eileen McAuley, RN, MPA
Chief Operating Officer

Richard Caroddo, MPA
Director, Business Development

Marjory Kadash
Senior Director, Project Management

Jessica Coutu
Senior Director, Contract Administration

Ewa Olesiak Deptuch
Senior Director, Finance

Alexandra Dilis, JD
Director, Quality Systems

Rachel (Rai) Neutel, MA
Administrative Director, Medical Affairs

 

David H. G. Smith, MD

David H. G. Smith, MD is one of the founding partners of Integrium and serves as the Chief Medical Officer. In this role, he oversees the Medical Affairs group, which provides pharmacovigilance and medical monitoring services. He also works closely with clients on program planning, protocol development and other key clinical matters. Dr. Smith brings substantial experience in clinical research and management to the operational capabilities of Integrium. His leadership has provided the visionary growth and ethical service bias essential in the contract services arena.

"Our existence and continued growth has always been in response to client need," according to Dr. Smith. "From the very beginning, our clients, both in the clinical development and marketing sectors of industry, came to us first for advice, and then for focused and efficient effort for the execution of well designed study programs as strategies. I am proud of the way Integrium has refined the critical relationship of scientific quality, regulatory muster and marketing relevance —understanding that all are essential to product advancement."

Dr. Smith completed his training in internal medicine and cardiovascular disease at the Veterans Affairs Medical Center, Long Beach, California and at the University of California, Irvine.

Dr. Smith has participated actively in research in the fields of hypertension, hyperlipidemia, diabetes, ischemic heart disorders and exercise stress testing. He has special interests in the study of the renin-angiotensin system, disorders of arterial compliance and endothelial dysfunction, 24-hour ambulatory blood pressure monitoring and the general pharmacotherapy of cardiovascular disorders. In addition to acting as Chief Medical Officer on a number of large international, multicenter clinical trials, he has authored numerous journal articles, abstracts, and book chapters and has formally presented at scientific meetings. Dr. Smith is a member of several specialty organizations and has been designated as a Specialist in Clinical Hypertension.

Along with his leadership role, Dr. Smith has served many clients in the area of scientific and regulatory consultation and has further assisted sponsors with representation and participation in meetings held with the US Food and Drug Administration, as well international regulatory authorities.

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Adam Steadman

As Chief Strategy Officer at Integrium, Adam provides additional leadership and strategic insight to the executive management team. His daily responsibilities involve carrying out our strategic initiatives regarding financial planning and reporting, asset management, disaster recovery planning, legal affairs and overall company compliance. Additionally, he oversees the management of several key departments, including Finance, Human Resources, Business Development, Quality Assurance, Facilities and Information Technology.

Before joining Integrium, Adam served as General Manager, CFO and CEO of several organizations. He has qualified as a Chartered Accountant, and holds a Bachelor of Accounting Science degree and a post-graduate Bachelor of Accounting Science degree (with Honors) from the University of South Africa in Pretoria.

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Eileen McAuley, RN, MPA

As Chief Operating Officer, Eileen has overall responsibility for the strategic planning and organization of the Contract Administration, Project Management, Monitoring Services, Regulatory Compliance, Biostatistics and Data Management departments, as well as Integrex. In this position, she ensures that all departments are providing the highest level of service and quality to our clients.

Eileen has worked for more than 18 years in the clinical research arena. Her experience ranges from Clinical Research Associate and Director of Project Management to Senior Director of Clinical Operations. She has a proven track record for satisfying clients, managing people and delivering complex projects on time and within budget.

Eileen received her BS Degree from Montclair State College in New Jersey and began her career as a registered nurse working in critical care. She has a Masters Degree in Public Administration from Seton Hall University, with a focus on Health Policy and Management.

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Richard Caroddo, MPA

In this role, Richard leads the activities of Integrium, establishing and expanding service relationships with biopharmaceutical clients, as well as directing the business development team in this process. Richard has been with the company since 2002, and he was previously the Associate Director of the business development group.

Richard has more than 13 years of experience in the pharmaceutical and healthcare industries. This experience includes significant business development and contracting activity with biopharmaceutical companies and healthcare providers. He has in-depth knowledge of the details and trends in the clinical development field and the broader business environment in which biopharmaceutical companies operate. He also has a keen interest in how companies adjust to rapidly changing conditions. Richard is an active speaker on clinical development topics at industry conferences and has published a number of articles in the area.

He received a Master of Public Administration degree from Columbia University and a Bachelor of Science degree from the State University of New York at Albany.

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Marjory Kadash

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Jessica Coutu

Jessica Coutu is responsible for the preparation, review and negotiation of contracts with sponsors, investigative sites, consultants and vendors. She is also responsible for the preparation of responses to sponsor requests for proposals and the financial account management of all awarded studies.

Jessica has more than 20 years of experience with proposal preparation and review, contract negotiation, budget development, monitoring and management. Prior to joining Integrium, Jessica was the Director of Contracts and Proposals for two other leading CROs. Before that experience, she was the Associate Director of Grants and Contracts for the Saint Barnabas Health Care System and previous to that was also a position as the Director of Research Development for the Children’s Hospital of New Jersey at Newark Beth Israel Medical Center. In these positions, she managed all clinical trial and basic research activities and was a member of the Institutional Review Board. She has extensive clinical and basic research experience from both private industry and academic institutions, and has additionally presented and published her research. Jessica earned her B.A. in Biology from the University of Rhode Island at Kingston.

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Ewa Olesiak Deptuch

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Alexandra Dilis, JD

Alexandra Dilis spearheads the Quality Systems function at Integrium - comprised of Clinical Quality Assurance and Internal Quality Compliance sub-functions. She is responsible for maintaining regulatory compliance of clinical trials and managing internal Quality Systems. Specifically, Ms. Dilis’ responsibilities include facilitating and hosting FDA and Sponsor inspections. In addition, she is responsible for managing Integrium’s Standard Operating Procedure (SOP) system, internal auditing, facilitating computer systems validation projects, and vendor qualification. She is also responsible for managing site, central laboratory, SMO, and vendor auditing programs within the scope of clinical programs and on behalf of Integrium’s clients.

Alexandra has more than 13 years of quality assurance experience in the pharmaceutical, biotechnology, and medical devise industries. Prior to joining Integrium, Alexandra was the Director of Quality Systems with a contract testing and auditing laboratory. Previously, she held key quality assurance roles in two CROs, a pre-clinical development laboratory, and a major biotech company. In these positions, she managed and actively participated in all aspects of the Quality Assurance function of these organizations. Alexandra’s selected achievements include successful implementation of the document control, Good Laboratory Practice (GLP) standards, and ISO 9001:2000 systems, as well highly effective management of 21 CFR 11 compliance programs.

Alexandra earned her Bachelors of Science degree in Business Management from Providence College and her Juris Doctor degree from the New England School of Law in Boston.

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Rachel (Rai) Neutel, MA

Rachel Neutel, MA, has more than 30 years of clinical research knowledge and experience in cardiovascular, endocrine, dermatologic and neuropsychiatric therapeutic areas. Within these disciplines, Ms. Neutel has been integral in the launch and development of the Medical Services Division to provide more comprehensive services in the areas of project medical oversight, drug safety and laboratory surveillance reporting, protocol waiver and compliance management and in-house secondary review of case book data safety and endpoint tracking. She leads of team of physicians, nurses and other research professionals to work closely with clients and Integrium project team colleagues and deliver diligence in medical services.

Ms. Neutel completed her undergraduate and graduate level education in psychology in South Africa and also holds specialty training and certifications in ophthalmic services, as well as being a Certified Radiology Technologist.

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