A clinical research organization provides many ongoing drug development services to pharmaceutical industries. It aids in the research and development of new cures and break through that will help in curing different diseases. The sponsors of this industry are able to manage many product development processes that are cost effective and efficient. The global research organization size is pretty huge and is increasing at a steady rate. The CRO completes its researchers faster than those compared to independent facilities. They also provide employment to many people as their research and development wing increases every year and there are more tests that are required to be run and studied consistently. Independent auditors for CRO carry out auditing services for various clinical trials. Their primary job is to check if the work flow is happening within the specified limits and that all the activities are carried out ethically. They have to prepare a pre-audit checklist in which they will specify the parameters they will use in carrying out the audit, then they have to physically go the site where the medical trials are run and audit them using those parameter, and lastly, they have to prepare an auditing report which will specify the workings of the trial based on those parameters. They usually maintain a check
list which has all the aspects which they need to cover while auditing for CRO, such as:
- Auditing the organization
- Auditing the staff
- Checking the staff for their training and development
- Auditing the premises
- Quality of the trial
- Maintenance of the area where the trial is being conducted
- Documents of the trial
- New drug study
- Certification, and much more
The auditors are mostly an outside party who work as freelancers with the CRO and undertake independent projects and then visit the site for auditing. They also need to audit the financial aspects of the medical trial and check if there is no illegal flow of money in the project.
Establishment of CRO in India was undertaken to keep a check on the medical trials that happen all across India. There are many number of CROs spread across in different cities of India which help in carrying out these projects. A CRO is an organization which offers support to pharmaceutical companies and the medical industry in the form of research services which they outsource on the basis of contracts. Each project gets its own independent monitor and auditor who help in the smooth functioning of the project. They can also be in the form of research institutions, universities, and support foundations. They also provide clinical help in studying the latest drugs and medical devices that are advancing in the medical industry. They can be made of small niche groups or can also be well set up large corporations. CRO’s help the medical trials from start to finish state and gets them the FDA approval along with putting them in the market and making the drug known by the consumers. They provide funding for new research and medical trials as well.