Rare Disease clinical research studies pose a different challenge in terms of project management, site selection and patient enrollment and retention. Rare disease – is a disease that affects fewer than 200,000 patients at any given time – demand a CRO with innovative strategies to manage a rare disease program. In particular, Rare Disease clinical research studies demand a full-service CRO with expertise in enrolling rare disease patients and maximizing site selection to create realistic study feasibility. Designing protocols and executing study design for scarce patient populations including pediatric patients who comprise 50% of these populations require medical doctors and pediatricians with specialized expertise. In addition, study design inclusive of a late phase component with access to Rare Disease patient registries is a critical tool.

HOW MEGALEK FACES THE CHALLENGES OF RARE DISEASES STUDIES:
● Site relationships with access to patient registries to drive patient enrollment
● Broad understanding of patient advocacy issues and organizations for support
● Physicians with Pediatric experience to understand the study design and complexity involved
● Regulatory understanding and consultation regarding the unique environment for Rare Disease studies

MEGALEK team is highly skilled in the scientific methodology, standard of care, evolving regulatory requirements and operational considerations that are necessary to bring drugs and devices that treat or prevent heart disease to market. Our vast experience in cardiovascular studies paired with our proven track record of success in the cardiovascular CRO industry ensures the flexibility to adapt to the unique needs of each cardiovascular trial.

In order to ensure success, MEGALEK helps our clients:
● Effectively plan and conduct cardiovascular studies for drug/device and cardiac safety
● Efficiently conduct large cardiovascular endpoint trials that demand rigorous safety requirements
● Seamlessly integrate cardiovascular trials with metabolic/endocrinology projects

MEGALEK with its unique approach to clinical studies, have earned a reputation for taking on some of the most complex and challenging cancer research studies. We help our clients:
● Develop successful strategies for even the most novel therapies
● Plan and conduct effective studies
● Compete successfully for high-performing sites
● Expedite study start-up and recruitment
● Navigate regulatory landscape to expedite approvals

MEGALEK expertise in ophthalmology studies and consistent track record of success as a full-service CRO ensures the flexibility to adapt to the unique needs of each ophthalmology trial.
Our therapeutically trained teams including clinical trial managers and program coordinators provide knowledgeable training to sites and help mitigate challenges.
Our physicians and professional staff understand the complexities of ophthalmology trials from the perspective of the Sponsor, the clinical investigator, the scientific leader, and the reviewer at the regulatory agencies. We bring these perspectives to each clinical trial that we conduct.
MEGALEK has vast experience partnering with the Sponsor’s choice of vendor for ophthalmology imaging to support the needs of each ophthalmology clinical trial.

Accelerate your study with MEGALEK noted medical and regulatory experts and highly experienced clinical trial management teams
Gain a competitive edge for your non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) study by partnering with a scientifically-driven clinical research organization that has the experience and relationships in place to get your study up and running as soon as possible. As a therapeutically-aligned CRO, MEGALEK has the relevant and recent gastroenterology and hepatology experience to successfully navigate the complexities and regulatory scrutiny involved with these programs. Our experience with our broad relationships with KOLs and investigative sites set you up for long term success.

● Well established relationships with KOLs and high producing quality sites
● Partnering with imaging core lab to support NAFLD/NASH studies, ensuring imaging components such as MRE, MRI-PDFF and MRS are seamlessly integrated into the complex structure of the overall trial
● Established processes and relationships for central pathology assessments
● Hands on regulatory affairs to guide you through the fastest path to commercial success