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Home » Clinical Trials Management (US & EU) Professional Certification Program

Clinical Trials Management (US & EU) Professional Certification Program (GCP00A1)

Certification Training
Rated 4.29/5
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Duration: See individual courses below for time requirements.
Method of Training: Online / Self-paced eLearning.
Credit Hours: See individual courses located below for total credits assigned to this program.
Self-paced Training: 24/7 access to course.
Enrollment Period: 6 months.
Catalog: Clinical Trials Management and Monitoring.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.

PRICE: USD $1295.00

Document a dedication to your career and job performance by earning a professional certification from Biopharma Institute.

Biopharma Institute ReviewsTraining Provided By: Biopharma Institute


This online professional certification program is for regulatory affairs personnel, clinical managers, project managers, investigators, and clinical research associates. It is also available to those interested in moving their career into these positions, such as clinical trial coordinators with the desire to grow their career in clinical research and regulatory management positions.

Assure Employee Compliance and Understanding for the GCP Standards: Courses included with this program are the following: 1) GCP: Preparing for an Audit or Inspection; 2) Clinical Trial Monitoring: Documentation Enclosure; 3) Clinical Trial Monitoring: Site Evaluation and Set-Up; 4) Clinical Trials and Drug Development; 5) Clinical Trial Preparation and Design; 6) ICH Good Clinical Practice (ICH: GCP); 7) The IND, How to Gain Approval for Clinical Trials in the USA; and 8) How to Obtain Approval to Conduct Clinical Trials in the EU.

Students can take the final assessment any number of times, as needed, to achieve a passing grade. Once all course requirements have been satisfied, a professional certification has been achieved.

Benefits of Getting Certified at Biopharma Institute

Throughout many of our courses, students will engage in active learning using interactive eLearning modules developed to promote the learning of key knowledge and information. For companies seeking a method to train employees, economically, without having to set aside an entire day for them to attend a live course, Biopharma Institute is the training partner you can rely on. Our training provides an effective, engaging, interactive, self-paced learning experience which fits in with most types of learners. We cater to both small-scale and large-scale training requests, customizing your employee's education.

Biopharma Institute LogoClinical Trials Management (US & EU) Professional Certification Program includes these individual courses:

GCP: ICH Good Clinical Practice (ICH-GCP): Good Clinical Practice (GCP) is a set of internationally recognized ethical and scientific quality requirements for designing, conducting, recording and reporting clinica | Learn more...
Duration: 180 minutes (3 CPD Credits)

GCP: Clinical Trial Preparation and Design: Worldwide expenditure by pharmaceutical companies on research and development is continually increasing. In the production of a new drug, most of the financial investment | Learn more...
Duration: 240 minutes (4 CPD Credits)

GCP: Clinical Trials and Drug Development: This course teaches the students about how clinical trials fit into the process of drug development. Key historical events which have led to the development of controlled | Learn more...
Duration: 90 minutes (1.5 CPD Credits)

GCP: Clinical Trial Monitoring: Site Evaluation and Set-up: The sponsor of a clinical trial needs to reach agreement with clinical investigators to conduct the trial. The suitability of investigators and their institutional sites, | Learn more...
Duration: 90 minutes (1.5 CPD Credits)

GCP: Clinical Trial Monitoring - Documentation and Closure: The sponsor of a clinical trial must arrange for it to be monitored throughout its duration to ensure that the rights and wellbeing of subjects are protected, the trial d | Learn more...
Duration: 180 minutes (2 CPD Credits)

GCP: Preparing for an Audit or Inspection: Good Clinical Practice (GCP) inspections and audits are carried out to provide assurance that: the rights, safety and welfare of clinical trial subjects are protected; th | Learn more...
Duration: 150 minutes (2.5 CPD Credits)

GCP: Application Process to Conduct FDA-regulated Clinical Trials in USA: The Investigational New Drug Application (IND) is a submission through which the sponsor seeks approval from the Food And Drug Administration (FDA) to conduct clinical st | Learn more...
Duration: 180 minutes (3 CPD Credits)

GCP: How to Obtain Approval to Conduct Clinical Trials in the EU: To conduct a clinical trial in the European Economic Area the sponsor must apply for authorization from the national competent authority (i.e. medicines regulator), and f | Learn more...
Duration: 180 minutes (3 CPD Credits)

Online Training: The Benefits of Remote Learning & eLearning

  • Immediate access to training: Instructions, username, password, and receipt of payment are emailed instantly upon online enrollment.
  • Optimized for learning: Courses include voice-overs, easy navigation, progress checks, and high-quality animations to increase retention of subject matter.
  • Self-paced courses: 24/7 access to individual courses for 90 days, and for professional certification programs for 180 days.
  • Flexible final assessments: Assessment testing include multiple-choice questions and can be taken repeatedly until a passing score is achieved.
  • Direct access to certificates: Certificate of completion is instantly available once course requirements have been fulfilled.
  • Verification of training: Certificates can be verified online, and digital badges are issued for all Professional Certification programs.
  • Tuition reimbursement: Some employers may reimburse for training expenses; check on your company's training reimbursement policy.
  • Financial assistance: Payment plans are available to those who qualify. These are offered when paying electronic invoices, online. You must first request an invoice to be considered. Alternatively, purchasing individual courses one at a time is also an option.
  • Purchase orders (POs) accepted: If a PO is required by your company, request an invoice to start the procurement process.
  • Corporate LMS compatibility: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems.
  • Secure and safe access: Website and LMS provide an encrypted connection with firewall protection and daily scans for optimal level of security and performance.
  • Career advancement: Professional certifications help demonstrate your interest and dedication to job performance, and may be helpful for those seeking a new career or transitioning to different positions within their organization.

Contact Us:

For more information on the Biopharma Institute's training programs, or to suggest a course, please complete the form located below. Alternatively, you may call toll free in the US: (888) 4-BIO-LRN, international callers can dial (201) 301-8370.

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