Gary Zammit, President and CEO
Jack of all trades, masters of none. Perhaps this description fits best to the current contract research organization (CRO) expanse, which is replete with players who take a generic approach to their business rather than focusing and excelling in one therapeutic area. This market condition has created several challenges for sponsors looking for efficient ways to develop drugs for the treatment of central nervous system (CNS) disorders. However, Clinilabs Drug Development Corporation has emerged as a specialty CRO that sets a new standard for best practices in CNS drug development. As the only global, full-service CRO exclusively focused on the development of neurotherapeutics, Clinilabs brings to bear its rich expertise, experience, and knowledge in developing new drugs for psychiatric disorders, neurological disorders, and substance use disorders. “We have specialized knowledge in the field of CNS therapeutics, a strong understanding of the patient populations in need, and the knowhow to implement the protocols and study designs that speed neurotherapetuics to market,” says Gary Zammit, President and CEO of Clinilabs. The company’s specialty expertise is matched by its good working relationships with investigator sites worldwide that can access, enroll, and accrue patients for CNS clinical trials.
A talented and skilled team is crucial for success in clinical trials. Clinilabs’ team of project managers, monitors, medical monitors, medical writers, biostatisticians, and data managers have deep experience in CNS. Besides, the team has genuine expertise in applying and standardizing the diverse array of assessment tools used in CNS trials. This has a game-changing effect when it comes to demonstrating drug efficacy in psychiatric, neurological, and substance use disorders studies. Zammit noted that “CNS studies usually don’t fail because drugs fail to show improvement from baseline, they fail because investigational drugs don’t separate from placebo. So you need experts who know the assessment tools and study designs needed to test your primary and secondary hypotheses if you expect to succeed.” At the outset of every assignment, Clinilabs is thorough in conducting feasibility assessments, giving clients expert feedback on their clinical trial protocols. Clinilabs also applies time-tested SOPs to accelerate project execution by having a well-defined project plan, which provides a roadmap to success. Milestones, key performance indicators, and quality parameters are tracked all along the journey for clients. All of this is done with emphasis on quality and compliance in what Zammit calls “our culture of quality.”
Nimble, agile, and process-driven, Clinilabs embeds quality in every aspect of the projects it runs. The firm adapts to the needs of each client and accommodates their special needs.
“We apply our standard operating procedures (SOPs) so clients can develop products quickly and reduce their time to market, and we adapt to each customer’s specific needs so our combined team can run smoothly and cost-efficiently,” says Zammit. In its 20-year journey, Clinilabs has played key roles in the development of 19 newly marketed products in ten different CNS indications.
You need experts who know the assessment tools and study designs needed to test your primary and secondary hypotheses if you expect to succeed
Unlike other CROs, Clinilabs stands rock solid behind its client in all of the stages of the clinical development process. It offers support right from the preparation of the investigational new drug (IND) applicaton to the submission of the new drug applications (NDA), carrying customers from first-in-human studies all the way through pivotal registration trials. This can especially be valuable for young biotech firms that are hard-pressed on resources and expertise. On the other hand, Clinilabs is increasingly becoming a partner of choice for large pharma companies that are seeking a CRO with specialization in the therapeutic area. This is a general industry trend. As large CROs get larger, customers seek value from specialty providers.
While Clinilabs provides all of the services you would expect from a global CRO, it has become well-known for excellence in data management for multicenter trials. The company has a core technology center that aggregates and processes clinical trial data centrally, keeping variability low and the study power to its maximum. Minimizing variability through centralized data processing is another key to running successful trials,” explains Zammit. “We have developed specialized methods to centralize CNS data and better handle data processing so our customers can see meaningful differences between active drug and placebo, or between active drug conditions, when such differences exist. This is yet another way we add value for our customers.”
Clinilabs’ approach is exemplified by its engagement with one of its clients who was on the verge of completing an IND application for their drug, a sleep therapeutic. The client was looking to carry out the first-in-human study for the new drug but wanted to move quickly into a proof-of-concept study with a patient population. Clinilabs worked to develop an adaptive design that combined FIH and POC studies, ultimately carrying the sponsor into phase 2 dose ranging and phase 3 pivotal trials in record time. During the entire process, Clinilabs brought its specialty team to work on the development program, establishing a close, long-term working alliance with the sponsor. It is this relationship that led to a successful NDA and a product that is now marketed in the US and other parts of the world.
Known for quality, Clinilabs has conducted over 600 clinical trial projects with operations in the US, EU, and China. The company has a history of performance excellence and holds an impeccable track record from regulatory and compliance perspectives. Clinilabs looks forward to expanding further geographically and is leading the way in patient-centric research and the use of telemedicine, portable e-pro, and wearable devices in CNS trials. “In 2020, we will reach a tipping point that will fundamentally change the way CNS trials are run, and we have no doubt we will be at the forefront of leading this change,” concludes Zammit.