April 01, 2009
New Director of Safety, Even More EmpiriStat Value
EmpiriStat is pleased to welcome Doug Domalik to our team as Director of Safety, thus expanding our already diverse field of expertise. A registered nurse with a Masters in Healthcare Administration, Mr. Domalik has over twelve years of clinical experience, including both pharmaceutical and behavioral health studies in all stages of clinical development (Phase I-IV).
As Safety Monitor for the National Institute on Drug Abuse (NIDA) Clinical Trial Network (CTN), Doug was responsible for the receipt and review of all Serious Adverse Events, protocol development, case report form design, safety training, annual report production, safety signal detection, and regulatory reporting, and he served as the Safety Representative on several Data and Safety Monitoring Boards.
Doug enjoyed his role as the Protocol Specialist for the NIDA sponsored trials, Prescription Opiate Abuse Treatment Study (POATS) and Starting Treatment with Agonist Replacement Therapies (START) studies, where his duties included protocol development, overall study management, regulatory oversight, vendor management, and coordination of the studies with NIDA and other business partners.
Doug’s pharmaceutical safety experience includes post-market monitoring and reporting for oncology, vaccine, and infectious disease agents. This experience includes production of Periodic Annual reports to the FDA and Periodic Safety Update Reports (PSUR) outside the United States, and responsibility for European Annual Reports, development of Risk Management Plans, and participation in several Safety Monitoring Committees.
This vast expanse of knowledge and experience adds even more value that EmpiriStat offers to our clients and partners. Having partnered with several large firms, Doug Domalik believes there are advantages for a company to hire a small firm like EmpiriStat, namely in the area of safety. “A small company can offer a level of service that would be lost in a larger company,” Doug said, adding that “many times large companies are hampered by their own procedures and policies or have a dogmatic view in meeting their clients’ needs [whereas] EmpiriStat can offer a singular level of service and will focus all efforts in meeting the client’s needs.”
Asked to identify the weaknesses of larger companies in the industry versus EmpiriStat’s personalized service, Doug commented that “Rigidity is the biggest shortfall I see in larger companies. They are not willing or not able to adapt quickly to meet needs, and are often hampered by the systems they have in place to process thousands of safety events, thus limiting their flexibility when dealing with differing safety reporting systems or processes. Unless the investment is worth their time they simply can’t adapt.”
Doug’s outlook fits well within EmpiriStat’s overall philosophy that we desire to work as long-term ‘partners’ with our clients rather than be just another vendor. “Organized safety regulations and guidelines [are] a relatively new concept to many Investigators and Scientists,” Doug said. “As with any new process the rules and guidelines are constantly changing. As a partner rather than a vendor we can listen to specifically what [the client] needs and offer the types of services they need and nothing else. We want to grow with our partners and as guidance and regulations change we can implement those changes with a minimal amount of time and resources.”
Doug Domalik expressed his excitement in joining the EmpiriStat team, stating “EmpiriStat is comprised of extremely professional people who have a varied array of expertise in both large and small companies. We have seen the shortcomings and know how to work around them.”