On-Site Training

We’re delighted to announce that our ICH E6(R2) GCP Investigator Site Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors.

That means when your site staff completes our GCP training course, it will be recognized by all TransCelerate member companies. This can save you from the wasted time and cost of undergoing duplicate training later.

Standardized Classroom Training Programs
Training your staff and keeping them current on regulations, procedures, and best practices is an important, yet never-ending undertaking. With our large repository of training modules, our expert trainers can do the job for you.

Customized Classroom Training Programs
Your company/institution is unique; you have your own culture, standard operating procedures, and projects. Polaris is experienced in developing customized training that communicates your goals, your way of doing business, and your project-specific information to your staff.

Why classroom training in today’s environment?
Web-based, computer-based, or other forms of individualized learning make financial sense in today’s economy and are the right choice for a wide variety of subject matter. But clinical research professionals must learn a great deal of new information and learn how to execute highly technical procedures. During instructor-led classroom training, participants receive immediate feedback and personalized attention, allowing them to master the subject matter more rapidly and completely.

On-site Classroom training provides:

• Opportunity to ask questions about project-specific issues without the concern of revealing confidential information to other industry attendees
• Personal interaction with industry experts
• Immediate verbal feedback to confirm that students have grasped prerequisite material before more complex material is presented
• Interaction with other learners which improves retention and allows students to benefit from the experience and questions of classmates
• Immediate adjustment of instruction to accommodate student needs and learning styles
• Simultaneous employee learning to promote consistency and standardization
• Opportunity for constructive team building among staff members
• Limited time away from the office and decreased travel costs

Polaris can provide training programs developed for entry-level and experienced personnel in GCP, CGMP, and GLP regulations. We customize our training for each client's needs.

• Overview of Drug Development
• Introduction to Clinical Research
• Regulations which Affect Clinical Research
• Detecting Misconduct and Fraud in Clinical Research
• FDA and ICH requirements for IRBs
• Role and Responsibilities of IRBs
• GCP Training for IRB Members
• GCP Training for the Clinical Investigator and Clinical Research Coordinator
• Developing Informed Consent Documents and Obtaining Consent from Research Subjects
• Adverse Experiences, Serious Adverse Experiences, Unanticipated Problems for Clinical and Marketed Products
• Regulatory Documents
• Source Documentation
• Basic Monitoring Skills
• Clinical Trial Material / Drug Accountability
• CGMPs from Discovery to Market
• CGMPs for the Workplace
• Understanding the USP
• Overview of the DSHEA Regulations
• Basic GLPs
• Laboratory Operations
• Regulatory Requirements for the Lab (nonclinical, post-approval, and manufacturing)
• What QC/QA/FDA Inspectors Look for in Laboratory Notebooks
• Preparing for a Regulatory Inspection
• FDA Interaction, Inspections, and Follow-up

If you don't see a particular course on this list, call us and tell us what you need.