A guide on the Contract Research Organization

A guide on the Contract Research Organization

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Some contract research organization offers some contract manufacturing organizationand it is the company to help by conducting some research for the sponsor company. The type of research can be anything like a preclinical development of new products or even post-marketing activities. However, it is important to follow some guidelines for it.

The contract research organization work with a number of sponsors and they refer the clients. A good CRO will have eminent and experienced staffs to offer good guidance for the staffs. There are different departments in the CRO and here are some of them.

 Medical functions

People in this area are medically qualified to design some clinical study. They highly help in developing clinical trial protocols and offer medical related input throughout the study. The designation of the professionals includes medical monitor, medical advisor, clinical physician, etc.

Regulatory submission team

This team completely assists in submitting the different documents and to have some approvals from a regulatory higher authority. Without the help of such experienced regulatory affairs person, it is not possible for the contract manufacturing organizationto work efficiently.

Clinical operations

It is the largest team in the organization and it consists of clinical research associates, clinical trial assistants, project managers, etc. Also, this team is responsible for the selection of clinical trial sites and it conducts some monitoring at the sits, assists in the study to help the management.

Data management

The data management team helps in designing different tools and database in collecting data. They also help in ensuring the data collected from clinical trials and clean to get ready for the trials. They will use only sophisticated software like SAS PheedIT, Open Clinica, Oracle Clinical, etc.

Biostatistics

This is the teams that help in analyzing the study data as protocol and helps in finding out whether the study has yielded positive or negative results. This further helps in generating statistical tables, figures, and graphs with appropriate interpretations and then pass to the medical writers for compiling into a complete report.

Medical writing

This team writes the study results in a way that can be easily understood by the public. They will also be involved in writing some study reports, writing promotional materials, study protocol, etc.

Quality assurance

This department conduct audits to make sure that all the guidelines, regulations and other standard operating procedures are been followed efficiently. They are also responsible for the overall quality of the organization.

IT support

They are also the part of the contract manufacturing organizationto take part in the IT related needs like purchasing, maintain some devices like desktops, laptops, telephones, software, and servers.

Admin and finance

This is the team to take care of administration and finance works. They also need to maintain them regularly and report whenever necessary.

Final words

The other departments like human resources and training and development also engage in the performance of the organization. As people in different departments are regular at their works the Contract Research Organization is enjoying its success!

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