Published by BioBuzz.io – June 8, 2023
Contract research organizations (CROs) are an essential key to a thriving life sciences ecosystem. Maryland is home to multiple CROs that provide broad support to the development of therapeutics across a broad spectrum of disease indications.
CROs are companies that provide research services to the life sciences community. They provide a wide range of services to client companies, including the management of clinical trials and analyzation of safety and efficacy data. Additional services include data management, logistical management, pharmacovigilance, data entry and processing, marketing and more.
Across the ecosystem, there are CROs that provide specialized services in different areas of the research process, from preclinical through the multiple stages of in-human testing and commercialization. BioBuzz takes a look at four Maryland-based CROs that specialize in the different stages of candidate therapeutics development in order to better support the life sciences community.
Noble Life Sciences – Preclinical CRO
Based in Sykesville, Maryland, Noble Life Sciences is a CRO primarily focused on providing comprehensive preclinical testing services for the development of drugs, vaccines, and cell and gene therapy products. Preclinical CROs such as Noble Life Sciences offer services such as GLP toxicology testing, Non-GLP toxicology studies, pharmacokinetics studies, and formulation development. The organization provides multiple services to clients, from proof of concept studies to preclinical safety and efficacy studies.
Through functional quality systems and experienced high-quality personnel, the company provides research integrity and regulatory compliance. Noble Life Sciences not only established an internal quality benchmark that calls for it to exceed the expectations of clients But also provides scientific and technical expertise whenever and where ever needed to enable successful completion of client projects.
The three core values of the company are “passion, integrity, and innovation.” As a CRO, Noble Life Sciences provides multiple client services for different modalities of treating diseases, including oncology, diabetes and infectious diseases. The organization works with cell and gene therapies, small and large molecules, and vaccines.
“As scientists and former CRO customers, we understand it is critical for us to offer only the highest-quality staff, facilities, oversight, compliance and results. We are committed to delivering on that promise every day,” said Srujana Cherukuri, PhD, CEO of Noble Life Sciences.
In addition to drug development, Noble Life Sciences is also adept with medical devices. The company provides a range of GLP and non-GLP testing services to ensure the efficacy and safety of medical device technologies. The company provides clients with significant expertise in orthopedic, cardiovascular, trauma, and wound healing testing models.
Navitas Clinical Research – Clinical CRO
A subsidiary of Navitas Life Sciences, Navitas Clinical Research is a CRO with more than 30 years of managing early through late phase clinical trials, as well as registrational studies. Clinical CROs like Navitas offer multiple services, including patient recruitment, clinical trial management, data management, and statistical analysis. The company’s expertise is in four key therapeutic areas – neurology, infectious diseases, oncology and musculoskeletal conditions.
When supporting clinical trials, Navitas Clinical Research provides assistance from site management to audits. The CRO supports clients from the early stages of identifying clinical sites through the monitoring of trials and prequalification meetings with the FDA.
Not only does Navitas Clinical Research support companies, the CRO has also supported work conducted by multiple federal agencies, including 10 NIH Institutes, the U.S. Centers for Disease Control and Prevention and the Department of Defense. The CRO has coordinated hundreds of clinical trials and epidemiological studies in a wide variety of therapeutic areas
“Our decades of experience enables us to predict needs, avoid common barriers, and move from a quick start-up through each research phase to a successful execution of your project,” the company says on its website.
CSSi LifeSciences – Regulatory CRO
Based in Linthicum Heights, Maryland, CSSi LifeSciences is a CRO that specializes in advancing drugs and medical device technologies from discovery through regulatory approval to commercialization. The organization’s “bread and butter” is in regulatory affairs. As a regulatory CRO, CSSi provides a range of services to clients, including regulatory strategy development, clinical trial design and management, and regulatory submission preparation.
Over the years, CSSi LifeSciences helped to bring more than 500 different drugs to market across the globe. Additionally, the organization has supported more than 250 successful medical device 510(k) Class 1-3 submissions. The company has experience navigating regulatory hurdles for medical devices in more 100 countries.
“CSSi LifeSciences offers regulatory affairs services to help minimize product development time and accelerate product approval. Our expert team provides guidance and solutions to regulatory hurdles. We prepare numerous agency submissions each year and are experienced in handling a wide range of therapeutic areas and project types, from small to large molecules, biosimilars, and generic drugs,” the CRO said on its website.
CSSi LifeSciences has extensive experience with multiple modalities and in multiple indications. The company supports precision medicine and personalized medicine approaches.
Emmes – Bioanalytical CRO
Founded in 1977, Rockville-based Emmes is a CRO serving clients across a broad range of therapeutic areas. As a full-service CRO, Emmes provides bioanalytical services, which involve measuring the concentration of a drug or its metabolites in biological samples such as blood, urine, or tissue.
Since its founding, the company performed thousands of clinical studies in areas such as oncology, infectious disease, ophthalmology, vaccine studies, substance abuse, neurology and more. The company specializes in hematopoietic stem cell transplantation (HSCT), cellular therapy and gene therapy.
The CRO provides clients with innovative study designs, regulatory strategies and global clinical trial execution capabilities.
Emmes has a long history supporting research on a variety of blood and marrow disorders, including lymphoma, leukemia, multiple myeloma, aplastic anemia and sickle cell anemia. The company also supports multiple projects aimed at orphan and rare diseases.
Since its inception, Emmes has capture approximately 200 million data points across 800,000 trials. The company has conducted more than 2,000 clinical trials in 75 different companies at more than 30,000 different trial sites.