The drug development process is quite complex, consisting of numerous steps. This includes discovering the drug, developing dosage forms, conducting research, carrying out clinical trials, seeking approval, and commercializing the drug. Drug development processes also require adherence to authorities like the FDA (Food and Drug Administration) and EMA (European Medicines Agency). This streamlined approach to the drug development process uplifts the safety standards and the quality of the drug. This also adds to the development time and costs. Thus, the drug development cycle needs to optimize all the operations in terms of productivity, time and costs without hampering any quality and safety standards.
The pharmaceutical organizations entrust the product development activities to the research and development department to undertake these important functions. Several research projects are initiated simultaneously to effectively manage the resources. However, while increasing the efficiency of the drug development process, it also increases the workload of the stakeholders involved. It can increase the workload of scientists, biotechnology companies, regulatory affairs teams, clinical trial teams, and project managers and can delay the timelines.
To reduce the workload of the stakeholders involved in the drug development process as well as to gain time in development, the projects are partially or completely outsourced to external agencies such as, CROs, CMOs, and CDMOs. All of these are contracted service providers that can help to undertake few of the activities of the pharmaceutical organization supporting the drug development process. These can potentially save time and help the stakeholders to focus on essential things requiring their special attention. It can also reduce the costs incurred by eliminating the need to invest in other resources such as machinery, analytical instruments, human resource etc.
What is a contract research organization (CRO)?
A Contract Research Organization (CRO) provides services to support clinical research. CROs act like partners to pharmaceuticals, biotechnology companies, and others, helping companies to conduct research and manage clinical trials efficiently and cost-effectively. These organizations can help in the following processes:
- Planning clinical trials
- Managing clinical trials
- Managing paperwork of regulatory affairs
- Monitoring the clinical trial process
- Data analysis
- Data reporting
- Safety and pharmacovigilance activities
Check out how CRO helps in different stages of clinical trials:
- Manage the entire clinical trial process, from Phase I, including safety and dose-ranging studies, Phase II and III registration studies. Phase IV post-market surveillance studies can also be entrusted to the CRO.
- Adhere to complex regulatory requirements in the country of clinical trials from agencies like the FDA and EMA
- Analyzes clinical trial data, tracks side effects, and assesses treatment efficacy
- Reduce operational costs of the company
In simple terms, CROs play the role of project manager for clinical trials. These organizations ensure that every clinical trial activity is on the proper track. The CRO market is growing exponentially and has a bright future ahead.
What is a contract manufacturing organization (CMO)?
The Contract Manufacturing Organization (CMO) is responsible for the manufacturing of the drugs. They are responsible for providing requirements like facilities, skilled workers, and equipment required for research. The services offered by them include:
- Production of the drugs/ API ( active pharmaceutical ingredient)
- Developing dosage forms for scale-up batches and its final packaging e ensuring product stability and quality
Check out how CMOs help in different stages of clinical trials:
- Ensures implementation of GMP (Good Manufacturing Practices)
- Ensures pharmaceutical drug development
- Handles manufacturing of clinical trial drugs at large scale
- Time and resource optimization
- Helps reduce overall costs
These organizations provide great support to pharmaceutical companies and associated companies by saving the time and money required to conduct development and manufacturing activities.
What is Contract Development and Manufacturing Organizations (CDMO)?
Contract Development and Manufacturing Organization (CDMO) plays the role of both CROs and CMOs. The services they provide include both manufacturing and drug development. It is one step ahead of just the manufacturing setup. They provide assistance in numerous tasks like:
- Research and development: CDMO helps in the preliminary stages of drug discovery and formulation. Their scientific expertise has proven to speed up the research process.
- Management of clinical trials: CDMO manages clinical trials by providing clinical trial supplies. By identifying the challenges in the clinical trial process, CDMOs have a chance to optimize the drug development process based on the available resources and situations. They are responsible for the quality of the product.
- Approval from regulatory bodies: It helps in seeking necessary approvals from the regulatory bodies. They have a deeper understanding of the global regulatory landscape, which can help speed up the drug approval process in the market.
Check out how CDMOs help in different stages of clinical trials:
- Manage activities from formulation development to clinical trial supply, reducing the need for multiple vendors
- Streamline processes, eventually cutting off the time between the phases
- Assist in scaling production for market distribution and ongoing compliance
With a wide range of services provided by CDMO, the drug discovery process complications are smoothened.
Conclusion
The drug discovery process is a multi-faceted journey. It requires accurate coordination, expertise, and resources. All three CROs, CMOs, and CDMOs play a vital role in the conduction of clinical research, drug development and manufacturing activities. These 3 organizations play varied roles, but all of them have the potential to smoothen drug discovery processes by supporting pharmaceuticals, biotechnology, and other companies doing research.
By outsourcing the services provided for particular stages of clinical trials, we can easily reduce the workload of the stakeholders involved. This strategy of outsourcing certain services can prove to be cost-effective, speed up time to release in the market, and channel their attention and skills to the specialized tasks that require their unshattered focus. Whether to select CROs, CMOs, or CDMOs all depends on which specific stage development cycle.