JeanMarie Markham, President & CEO
Every successful entrepreneur started somewhere.
For JeanMarie Markham, a registered, trained nurse with over 30 years of experience, the leap into the world of entrepreneurship was more of a natural evolution. Born out of a personal pain-point, the importance of accessible new medical treatments dawned on JeanMarie, the founder, president and CEO of Clinlogix, when her grandmother was suffering from severe congestive heart failure. The only medication that improved her condition was not approved by the FDA and was still undergoing clinical trials. The purpose of clinical trials is to evaluate efficacy and safety of the investigational project. This pivotal moment piqued her interest in clinical trials and presented an opportunity to work on advancing these therapeutic innovations and emergent technologies safely to market, ultimately improving patients’ quality of life. Fueling her passion to drive the field of Clinical Research development services forward, JeanMarie leads Clinlogix, a Clinical Research Service Organization (CRO), with the mission of providing exceptional service and resources to the biopharmaceutical, medical device, and diagnostic industries and accelerating clients’ innovative investigational products from “bench to bedside/concept to cure.”
Clinlogix assists clients in the pre-clinical development and the post-marketing space with specialized clinical regulatory strategy, clinical evaluation, pharmacovigilance, post-market surveillance, and reporting services.
“Clinically, the delivery of pharmacovigilance and vigilance services are undergoing a paradigm shift,” mentions JeanMarie, “Sponsor organizations are required to be more proactive in providing reliable safety information to clinical channels involving physicians, medical staff, and patients.” According to the industry veteran, there is a growing propensity in the PV space to utilize big data and analytics to drive better healthcare decisions.
Jen Kratz, Director, Safety Services
This calls for a standard platform that allows clients to have seamless access to big data, and aggregate responses to decide whether to outsource end-to-end vigilance tasks or the specific elements of the process.
Clinlogix’s holistic PV program lead by Jennifer Kratz; offers Sponsors safety services customized to meet each individual client needs using the global gold standard of Oracle Argus. Clinlogix’s safety team can provide full safety services or just the safety services needed by the client. “Clinlogix’s uniqueness stems from its ability to assist its clients irrespective of the stage of their project,” states Jen Kratz, Director, Safety Services, Clinlogix, “be it the beginning, intermediate or the ending of a project, Clinlogix effectively helps clients to achieve the objectives.” According to Jen, the organization is designed to maintain balance in the workload by enhancing the skills and experience required by the clients. In doing so, Clinlogix enhances the business vision based on the budget, projection time and similar factors.
Recently, Clinlogix assisted an organization where a PV professional had resigned without any suitable replacement. The organization approached Clinlogix to collaborate, thereby ensuring consistency in the completion of tasks and simultaneously streamlining the processes and proactive planning of their products. Clinlogix helped the company to successfully manage their program and to launch new ones. Regulatory authorities globally are requiring more clinical evidence to gain and maintain product approval and safety, in alignment with these global requirements for industry. Jen adds, “We work with sponsors to develop these robust vigilance programs that encompass both pre- and post-market data.” The entrepreneurs unanimously boast of the company’s expertise in understanding the regulatory constraints in different marketplaces and equip clients with solutions to comply with them.
Clinlogix currently has office locations in Germany, Columbia and Japan, along with aggressive expansion plans in Australia and New Zealand.