Contract Research Organisations (CROs)
A CRO company provides clinical trial management services to pharmaceutical, biotechnology and medical device manufacturers. Running a clinical study is much more complicated than you might think due to the number of people involved, the resources required, and the rules that must be adhered to.
The CRO will ensure that the drug trial is properly managed, and that it complies with the Good Clinical Practice and Harmonisation Guidelines.
Services offered by a CRO
- Initiating and monitoring clinical trials
- Developing and revising protocols for trials
- Adapting necessary documentation to the legislation
- Obtaining approvals from the Clinical Research Ethics Committee and Regulatory Authorities
- Designing and preparing case report forms
- Sample selection
- Controlling compliance with protocol and procedure for the study
- Managing data and generating reports
- Controlling and storing documentation
What's the difference between a CRO and a pharmaceutical company?
A pharmaceutical company is usually focused on innovation, whereas a role within a CRO is faster-paced. A CRO’s tasks tend to be much more clearly defined – that’s the nature of collaborating with a paying client.
Working for a CRO means you have the option to take on a variety of different projects, whereas a pharmaceutical company will give you more opportunities to specialise in a particular area of interest.
What is CMO? Contract Manufacturing Organisations (CMOs)
These companies usually split their services into two main activities:
- Primary manufacturing: the synthesis of a drug substance involving its active ingredients
- Secondary manufacturing: the formulation of the drug substance into the final drug product
CMOs can specialise in manufacturing a range of dosage forms, from solid tablets and capsules to injectable and topical medicines. They are in a position to carry out the manufacturing process, from sourcing raw materials and prototyping samples to scaling up production, packaging and delivery.
This aids the client by allowing them to focus on the other areas of their business, such as research or marketing. If the client lacks the facilities required to actually produce a product, CMOs step in to manufacture for them.
What key skills are needed to work in these sectors?
- Process Improvement
- Continuous Improvement
Research and Development in:
- Analytical Chemistry
- Formulation Chemistry
- Organic and Medicinal Chemistry
- Structural Biology
- Upstream and Downstream Processing
Why do companies outsource these services?
By outsourcing, pharma and biotech firms are able to develop a strategic partnership with CROs and CMOs. This means that they can manage their internal resources and costs more efficiently.
If clients are unable to complete the tasks ‘in house’, outsourcing is a cheaper option as it means the firm itself does not need to provide the infrastructure, space or manpower to run clinical trials.
In recent times, the demand for outsourced services has been steadily increasing. This has resulted in a huge focus on talent across CROs and CMOs.