Ella Grach, MD, Founder & CEO
As one of North America’s largest integrated networks of wholly owned Phase I-Phase IV clinical research trial sites, Wake Research continues to set the pace as a leader in research for the biopharmaceutical, biotechnology, medical device manufacturing, and pharmaceutical industries. Headquartered in the world’s epicenter of scientific and medical progress, the Research Triangle of North Carolina, Wake Research’s unique network of 18 sites across the country and relationships in Europe orchestrates a variety of studies among a wide range of therapeutic areas and a diverse pool of patients in dermatology, women’s health, neurology, gastroenterology, and psychiatry, among other medical specialty areas.
The Wake Research team continually strives not only to improve outcomes and deliver life-changing therapies for patients, but also to shorten drug development time with better access to patient populations and optimized value for biopharmaceutical companies. “Our mission is to enhance healthcare by preventing diseases and accelerating cures through clinical trials,” says Ella Grach, MD, President and CEO of Wake Research. Wake’s centralized marketing, call center, regulatory, and contract services allow for accelerated study start and enrollment.
Having conducted thousands of clinical trials since 1984, Wake Research maintains its own proprietary patient database of over two million patients across all ages, ethnicities and demographics. The company provides its clients appropriate access to its patient population across Phase I-IV clinical trials in a variety of indications, including the ability to focus on minority populations when needed. Wake has been and remains committed to patient diversity in all their trials. Wake Research is known for performing on large vaccine trials as well as specialty population Phase I studies (e.g. Parkinson’s, Alzheimer’s, Crohn’s and Colitis) with its brand new pharmacy and state-of-the-art confinement unit.
Rendering medical research services across these specialties is the mission of Wake Research’s physician network of over 1000 physicians, plus 100 key opinion leaders and principal investigators, all of whom are committed to providing the highest quality of patient-centric care. Wake Research’s integrated network is unique in that all research sites are owned by the same company, ensuring consistency across the network in standard operating procedures and best practices. Additionally, the company regularly conducts internal data auditing for quality control and quality assurance programs, further strengthening its value proposition.
Joining Forces to End the Global Pandemic
In 2020, Wake Research was awarded a number of Phase I-III clinical trials related to the historic global efforts to fight the COVID-19 pandemic. Working with a variety of sponsors on multiple investigational therapies, Wake Research is conducting vaccine studies in sites across the country from California to North Carolina, as well as studies for inpatient and outpatient treatments of COVID-19 patients, COVID tests, and COVID prophylactic antibody therapies. As part of Operation Warp Speed, Vice President Mike Pence and FDA Commissioner Stephen Hahn visited the Research Triangle in July of 2020 and met with Wake Research CEO and other company representatives to officially commence the Administration’s initiative to find a safe and effective COVID vaccine.
Innovating and Integrating Clinical Research with Care
Our mission is to enhance healthcare by preventing diseases and accelerating cures through clinical trials
In the endless pursuit of its mission to continually enhance healthcare while meeting the needs of CROs and sponsors, Wake Research approaches clinical research as a care option. By volunteering to participate in clinical research, patients can actively engage in their own health management, further enhancing the quality of studies and health outcomes.
For optimal patient convenience and safety, Wake Research has recently increased telehealth and virtual visit options for clinical trial participants when applicable for non-life-threatening conditions, such as routine follow-up visits, dermatology visits, and other simple patient encounters. Utilizing secure, HIPAA-compliant video technology, patients can see their physician on their computer screen and interact in real time. Enabling patients to speak with a physician from home without risking exposure to illnesses or other health hazards has been particularly important throughout the COVID-19 pandemic. While many clinical trials were forced to pause operations, telehealth capabilities allowed many of Wake Research’s studies to continue relatively unaffected, despite periodic lock-downs and shelter-in-place mandates due to the pandemic.
Comprehensive Clinical Services and Results
Each time Wake Research engages with a pharmaceutical sponsor to conduct a new study, the process begins with a feasibility analysis to determine the readiness of the company to conduct a given trial with efficient performance and results.
“We are a metrics-driven company, we can go into our patient database, look at the protocol’s exclusion and inclusion criteria, and definitively conclude right away whether or not we can perform the trial at our various facilities,” Dr. Grach explains. She adds that clients are empowered with the capability to initiate one streamlined contract for up to 18 Wake Research sites, and complete one set of regulatory submissions to the Food and Drug Administration (FDA) and Institutional Review Board (IRB). Wake Research’s clients also benefit from integrated standards and the convenience of working with a single point of contact for site identification, rapid subject recruitment and retention, advertising, contracting, study implementation and trial management, in addition to centralized, in-house quality assurance and quality control programs executed by expert industry auditors. “We are a one-stop-shop for pharmaceutical sponsors and CROs,” states Dr. Grach.
Even for studies with some of the largest, most extensive, and specific enrollment needs, Wake Research delivers. Dr. Grach recalls one request for 7,000+ patients for a trial that was being conducted by the world’s sixth-largest CRO. Wake Research leveraged its unique patient engagement strategists and rich patient database to provide a centralized recruitment campaign resulting in the required patient population, ultimately accounting for almost half of the CRO’s enrollment goal, despite Wake Research only accounting for 20 percent of the study’s total participating sites. These exceptional resources and capabilities, bolstered by the drive of Wake Research’s leadership team to exceed sponsor expectations, are what have established Wake Research as a national leader in clinical research standing ready to meet all clients needs.