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What are the services of the Clinical Research Consultant?
by John Smith Digital Marketing ExpertClinical research consultant is one of the medical device clinical trials organization (CRO), and the world’s only Medical Research Organization (MRO). This is providing comprehensive quality systems consulting services in essential aspects of clinical research and statistical support. This clinical and statistical is covering all manner of technologies, therapies, indications, and business strategies.
Clinical Research Consulting is one of the full-service organization specializing in monitoring, project management, training, and education services. CRC is committed to raising standards within the pharmaceutical and biotechnology industry. Other services are available upon request include; auditing, medical writing, protocol development and Case Report Form design. There are some services the following :
Clinical Monitoring Services
Monitoring of Clinical Trials is one of the important in assuring safe subjects, quality data and a well-executed study. For each phase of clinical monitoring will be provided to the client in a timely manner, a complete, detailed report after each completed clinical monitoring service.
1. Pre-Study / Qualification
Clinical research consultant is initiating a complete assessment of each clinical research site, capabilities of staff and evaluates the site's ability to adhere to FDA regulations, Good Clinical Practices (GCP's) and the overall conduct of clinical trials.
2. Clinical Monitoring Initiation
Clinical research consultant is providing full initiation of the clinical research site. But it is not limited such as review of the protocol, regulatory documents, Case Report Form, enrollment requirements, investigational drug and responsibilities for the conduct of the clinical trial.
3. Interim Clinical Monitoring
CRC is conducting ongoing clinical monitoring throughout the conduct of the clinical trial. Activities include informed consent review, eligibility verification, Case Report Form and source documentation review, data retrieval, ongoing maintenance and review of regulatory documents, assessment of protocol adherence and drug accountability.
4. Close-Out
Clinical research consultant is providing final retrieval of all data, resolution of data clarification queries, assessment of regulatory documents, review of site regulatory obligations, investigational drug accountability and return.
Clinical Research Project Management Tasks
There are some project management tasks of Clinical Research Consulting the following:
- Contract Negotiation: This is providing complete contract negotiation that is not limited to site negotiation, payment for services & consulting outsourcing for the conduct of clinical trials.
- Contract Management: It is providing tracking, oversight, and execution of contract/grant payments to clinical research sites and outside consultants.
- Outsourcing Management: It will be maintained and execute oversight and management of contractors including CROs, central laboratories and independent consultants.
- Timeline Tracking: It will be identifying and assist clients in establishing and maintaining study milestones and deadlines throughout the conduct of the clinical trial.
- Trip Report Review and Submission: This will be collecting, review and submit monitoring visit documentation and assume the responsibility for submission to the client.
- Quality Assurance Program: It has designed and implemented a proprietary Monitor the Monitor program. Clinical Research Project Managers are auditing monitored research to ensure quality monitoring and adherence to company standard operating procedures.
Training And Education Services
CRC instructors can tailor these existing proprietary programs to better suit your needs and areas of focus within your organization. This training facility has required a minimum of five attendees for in-person education programs. These fields include clinical research coordinators, clinical research associates, research nurses, regulatory coordinators and/or data coordinators. The course can be serving to sharpen the skills of the research professionals within your organization.
There are following clinical research education program:
- This course is covering developed clinical research modules that are covering various topics critical to understanding the clinical research industry.
- At the end of each module, there are a series of test questions that will be challenged by your knowledge of the material reviewed.
- In addition, you will experience real-life scenarios at the end of each module where challenges, common obstacles and real-life experiences are shared with these students are relating to the specific module topics.
- Lastly, upon completion of the modules, students will have participated in a final exam that will be covering all of the material reviewed in the course.
- Upon completion of this education program, test results will be provided to the students via US Mail along with a Certificate of Completion which will be documenting their participation and education fulfillment.
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About John Smith 
Digital Marketing Expert
343 connections, 4 recommendations, 973 honor points.Joined APSense since, June 14th, 2012, From Delhi, India.
Created on Mar 16th 2020 22:10. Viewed 429 times.
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