Clinical trials play an essential role in developing products to combat disease, treat chronic and degenerative diseases, and improve the health of people around the world. The large volume of new drugs, therapies, and devices under development has dramatically increased the number of clinical trials required to evaluate them properly.
As of November 2019, the National Library of Medicine (NLM) reported nearly 16,000 active clinical trials in the U.S. alone. While is FDA-mandated for all new treatments, including drugs, medical devices, vaccines, and gene therapies—these studies also produce crucial data for making other care decisions.
Clinical studies are classified into two main groups based on the research protocol and whether or not participants receive medical interventions as part of their testing. These categories are defined as:
It is commonly referred to as clinical trials. Investigators assess participant health outcomes based on specific interventions administered as part of the research protocol to test the safety and effectiveness of a candidate drug, therapy, or experimental treatment.
Investigators assess participant health outcomes as established in the research protocol without administering interventions or procedures.
Let’s Look At the Areas of Therapeutic Clinical Trials Focus:
Clinical Research in Autoimmune Diseases:
Understanding the complex conditions that cause autoimmune diseases and the medical complications experienced by patients with these conditions. Anticipate challenges and proactively navigate rapidly evolving regulations, operational complexities, and tight timelines.
Cardiovascular CRO for Clinical Research:
Effectively plan and conduct cardiovascular studies for drug/device and cardiac safety. Also, conduct large cardiovascular endpoint trials that demand rigorous safety requirements.
Endocrine & Metabolic:
In these clinical research therapeutic areas, professionals can help navigate the complexities and regulatory scrutiny of endocrine and metabolic development programs.
Strategic leadership to design and execute your nephrology trials supported by dedicated renal experts and considerable experience.
Maximize the efficiency of your infectious disease program by leveraging our significant preclinical and clinical therapeutic specialties expertise. The preclinical site has the advantage of BSL-2 designation because of its NHP population. Clinically, experts in infectious disease have conducted more than 140 studies for acute or chronic infections performed in healthy participants and patient populations.
Oncology expertise can move your compound into patients and have clinical expertise with several non-cytotoxic oncology compounds. Drawing on a broad range of preclinical experience in oncology, professionals are accustomed to fast-tracking development so that you can proceed to patient studies as rapidly as possible.
Support the development of your immunology compound by working with a CRO with relevant therapeutic area expertise and the flexible, collaborative approach you need. Professionals analyzing immune endpoints are best positioned to meet your molecule’s development needs. Biomarker panels, including the complement pathway and flow cytometry assessments, will allow you to seamlessly translate your preclinical findings to the clinical phase.