Numerous discovery, development, and research stages exist before a new drug, pharmaceutical treatment, or medical device hits the market. Each of these stages brings unique challenges, and success depends heavily on the resources available to the sponsor of the novel treatment.
Contract research organizations (CROs) provide specialized research, such as preclinical research, clinical trials, and a range of other research-based offerings, for biotechnology, pharmaceutical, and medical device companies on a contracting basis. CROs assist in bringing new drug discoveries to market by easing the strain on sponsor resources and eliminating the need to hire full-time preclinical/clinical trial staff.
CROs provide services based on the specific needs of pharmaceutical or biotechnology companies. Services typically vary depending on the complexity of preclinical and clinical trials, the area of therapy, and resource flexibility. By outsourcing to a CRO, sponsors save time and funding, accelerating the drug development process and creating a network of experts to support the product throughout its lifecycle.
Generally, CROs control product compliance preclinical and clinical trial management. This includes managing patient recruitment, data collection, site selection, trial monitoring, and regulatory and ethical compliance.
In the early stages of drug development, several discovery and validation steps are necessary to prepare a possible treatment for preclinical trials. Discovery CROs streamline the product development stage by offering target identification, lead optimization, and preliminary testing.
Discovery CROs increase the likelihood of market success and shorten the development process by utilizing their specialized expertise in market launch and research. They will also manage drug development projects and provide explorative pharmacology and toxicology necessary to assess the validity of potential treatments.
Human clinical trials are high-stakes experiments for novel treatments and as such, must be prepared carefully. Preclinical CROs handle all of the product development to prepare a therapy for clinical trials, making them essential to assessing the safety and efficacy of a potential drug before it advances to human clinical trials.
Preclinical CROs provide detailed testing and safety assessment using pharmacology, toxicology, pharmacokinetics, and pharmacodynamics. These tests evaluate the potential risks and threats the treatment can cause when administered on a broad scale, including carcinogenicity, mutagenicity, reproductive toxicity, allergic or inflammatory reactions, bioavailability, and biocompatibility.
Preclinical CROs will also modify the drug formulation throughout the process to adjust for dosing and testing results for the most effective final parameters.
Multiple phases of clinical trials are essential for pharmaceutical and biotechnology companies to access the market, and market success hinges on achieving precise and high-quality trial results. Clinical CROs manage all of the planning and execution of clinical trials. From patient recruitment to experimental design to data analysis and collection, clinical CROs are pivotal in facilitating the collection of reliable and reproducible data.
Clinical CROs will also ensure regulatory compliance by preparing and submitting Investigational New Drug (IND) applications, New Drug Applications (NDA), and Investigational Medical Product Dossiers (IMPDs). They will also prepare and submit data and press releases to scientific journals to expedite the peer review process.
Due to their extensive experience completing clinical trials, clinical CROs act as a guide for sponsors during this complex process. By connecting sponsors with reliable hospital sites and patient pools, they provide an integral helping hand throughout clinical trials.
Also referred to as a central laboratory, a laboratory services CRO provides testing and other laboratory services to support clinical trials and product research and development. Sponsors will utilize laboratory services CROs to ensure accurate and reliable experimental data to assess the safety and efficacy of investigational drugs and products.
Laboratory services CROs provide a wide range of tests covering both surface-level and in-depth study areas. Blood tests, such as hematology, PK analysis, and biomarker analysis, are offered along with more genetic testing like sequencing. PCR, cell sorting and separation technology, and flow cytometry to identify genetic variations and their impact on the body when using investigational drugs.
Laboratory services CROs will also provide documented clinical trial patient sample handling and storage solutions that are necessary for regulatory compliance.
To maintain their wide range of offerings, CROs will have a highly varied staff of skilled individuals, mostly holding degrees in pharmacology, toxicology, chemistry, or biology. To ensure smooth clinical trials, these individuals are specially trained to fulfill various roles during product development, such as operations managers, laboratory managers, research associates, and trial assistants.
Data, quality, and statistics experts are also on CRO teams to manage clinical trials and other pre-market testing data. In addition to scientific expertise, CROs are normally equipped with a knowledgeable business team. They can provide opinion leaders, legal professionals, and other business development specialists to streamline the product launch process.
Sponsors of drugs, medical devices, and biotechnology don’t always have the specialization necessary to develop drugs or manage their intended product. CROs are important to clinical trials because they fully take on specialized tasks outside the sponsor’s scope.
A CRO contract is the best option to ensure technical proficiency and high-quality research results. By hiring a CRO to handle clinical trials and testing, sponsors can refocus on their business strategy, market access, and funding.
Because of the extensive network of established relationships within a CRO, outsourcing niche development projects reduces operational costs by avoiding capital investments in advanced equipment and personnel.
CROs most efficiently employ sponsor resources due to their web of reputable trial sites, patient pools, and possible investors. Because of their history of managing clinical trials, CROs have developed partnerships with clinical sites and investigators across various therapeutic areas.
They also use this network to aid the trial process by indicating which hospitals and doctors are the most reliable source of patient recruitment and clinical trial site access.
Errors during the clinical trials of a new investigational treatment can jeopardize future therapy’s launch timeline and credibility. CROs specialize in managing clinical trials and maintaining regulatory compliance, decreasing the regulatory burden on the sponsor and the possibility of error. CROs optimally maintain good clinical practices by providing extensive quality assurance and site monitoring.
Similar to CROs, CMOs, or contract manufacturing organizations, provide drug manufacturing services (as opposed to research services) on a contractual basis. CMOs are helpful to companies that lack the expertise or resources to manufacture their products in-house or are looking to outsource manufacturing to meet demand or reduce costs. CMOs are equipped with access to a wide range of manufacturing facilities that are capable of producing new products more efficiently and cost-effectively than in-house manufacturing.
There are two main types of CMOs:
CDMOs, or contract development and manufacturing organizations, offer additional drug discovery and development services. CMOs primarily handle manufacturing services, whereas CDMOs manage the entire process from product discovery to manufacturing, more similar to a CRO.
Although similar sounding, the distinction between CROs and CMOs can be demonstrated through their core focus and project objectives.
CROs specialize in research and development, clinical trial management and execution, and regulatory compliance and support. The main objective of CROs is to get new products through the trial period and ready for market use.
CMOs and CDMOs concentrate more on the physical development and creation of the product, providing support and management of discovery, manufacturing, and production.
CROs are responsible for the successful trajectory of many popular modern medical products and play a major role in the current landscape of the pharmaceutical and biotechnology industries. The regulatory field of medical product development is complex and daunting, and maintaining all components can detract sponsor energy from important business management.
Innovations in healthcare can provide necessary treatments, and CROs effectively shepherd novel and influential treatments to market safely, putting them in the hands of the doctors and patients who need them sooner rather than later.
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