A contract research organization (CRO) provides research services for the pharmaceutical, biotechnology, and medical device industries. These organizations are responsible for the design, conduct, and analysis of studies for clients. They perform research on a contract basis and are highly skill and experience in their fields. In addition to these core areas, Clinical Research Organization can also provide data management services for clients.
Regulatory affairs professionals usually earn an undergraduate degree in a field like life science, clinical science, public health, engineering, business, or the liberal arts. However, many prospective employers prefer those who have hands-on experience and advance knowledge of regulatory processes. An advance degree opens doors to even more exciting job opportunities in this field.
Regulatory affairs is a key part of the drug development process. From preclinical toxicology studies to the creation of an NDA, regulatory affairs has a hand in nearly every phase of a drug’s development. It also involves post-commercialization activities, such as expansion of information for a new label, submission for new indications, new formulations, and post marketing surveillance of safety. Regulatory affairs also oversees the advertising and communications of a new product, such as press releases, marketing materials, and brochures.
Regulatory affairs professionals are scientists involve in the development of new drugs. They are experts in compiling the information required for new drugs and representing that information to regulatory authorities. RA professionals are involved in every step of the drug development process, from preclinical studies to clinical trials to post commercialization activities.
Regulatory affairs professionals must have a comprehensive knowledge of regulatory guidelines. The key to successful regulatory affairs is the ability to communicate with regulators and ensure timely approval. They must also have the ability to make clear, consistent, and complete regulatory documentation. They must also be able to develop strategies and tactics to work effectively with regulatory authorities.
Data management is a fundamental function of a clinical research organization. It ensures the integrity of the data collected by the clinical trial. Its processes weave throughout the entire clinical study, ensuring a data audit trail. If you’re unfamiliar with this process, Egnyte has experts ready to answer your questions. With over 16,000 satisfied customers and millions of users around the world, they know it’s important and can guide you through the process.
Data managers typically have a degree in biomedical sciences or a related field, and knowledge of computer applications. However, some organizations prefer someone with a combination of formal education and work experience. Paramedical professionals, such as medical coders, are also capable of filling this role.
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There are many tools available to aid in the process
Many of these tools have built-in regulatory compliance and are easy to use. Some applications are certified by the Society for Clinical Data Management. There are also several open-source software tools for data management. These include openCDMS, OpenClinica, and TrialDB. These tools can be tailored to fit the specific needs of a clinical research organization.
The Society for Clinical Data Management (SCDM) publishes the Good Clinical Data Management Practices (GCDMP) guidelines to guide CDM. The document was first published in September 2000, but has undergone several revisions. The most current version is the July 2009 GCDMP. The guidelines cover accepted and best practices in CDM. The GCDMP comprises comprised of 20 chapters. These chapters address the various phases of the process.
Data managers have a crucial role in a clinical trial. They are responsible for maintaining the integrity of the data and ensuring that the trial is done in the most efficient way possible. The process of data management begins with the creation of the clinical trial. A clinical trial is not complete without a protocol.
The clinical data management process involves the creation, approval, and management of data. Afterwards, the process moves to the design/development phase. This includes the creation of the protocol and the development of the forms and databases. It also involves statistical planning, database setup, and validation.
The field team of a Clinical Research Organization includes several professionals who provide services related to clinical trials. Typically, these individuals serve as liaisons between the research company and the medical community. They also educate the medical community about current treatments and diseases and provide education to customers. The team is often deployed well before the product launches in order to assess receptivity from the medical community.
The field team of a Clinical Research Organization also collects clinical trial data, including the study’s patient outcomes. Traditionally, this data was collected using paper case report forms. This made data entry and management complicated. However, new technology solutions have made the process easier and more efficient. Today, site staff are able to input patient data directly into case report forms. This group also is responsible for managing clinical technology solutions, including the Trial Master File (TMF) and Case Report Forms (CRFs). These teams are also responsible for retiring old technology solutions and on-boarding new ones. As such, they are the technology backbone of a Clinical Research Organization.