Research Dynamics provides on site classes for Investigator Sites, SMOs, Sponsors, and CROs. Each class includes case studies, role plays and "tools of the trade" so each student can practice the skills in the classroom. The participants can use your procedures during the class, so they can apply them immediately upon return to the job.
The class can be economical "off the shelf" programs or can be customized to fit your needs. We can also design training materials to your specifications and procedures, and using your SOPs and forms. One of our expert trainers will come to your site and present the exact training program that you want and need.
On site training is often the most cost-effective option for large groups. Your business can save on airfare, hotel and other expenses that accumulate when budgeting for a large group. More employees can attend the class at a lower cost by minimizing travel costs and time away from the office. In fact, the cost of a two-day basic CRC course for a large group of people at your site is equal to sending approximately three students to a regional training session!
Benefits of On Site Training: Allows participants to learn in a familiar environment while using their standard procedures and forms. Company-specific issues can be discussed and resolved. More employees can attend the class at a lower cost by minimizing travel costs and time away from the office.
Contact us at 585-381-1350 x246 for more information.
Sample of courses below:
This course provides information on Clinical Quality Assurance and practical techniques and procedures for conducting CQA audits. Developing and implementing CAPA plans after the audit are also discussed. Our trainers are active auditors so we have up-to-date information, examples, and experience to share with you during the course.
Good Clinical Practices (GCP) and ICH (International) requirements for any of the following audiences:
This course reviews all the requirements for GCP according to FDA and international (ICH) standards. The course is customized to describe the specific activities that each entity or role must perform to meet these GCP requirements.
The “course” can be 2 hours long or up to 3 days long depending on the depth of the details and whether it is interactive with workshops or a straight lecture. It can be given in-person or via webinar.
This course can be designed to discuss more advanced issues in GCP or specific areas that need refresher information.
Course in how to monitor a study teach the knowledge and skills of monitoring drugs, biologics, IVDs, or devices (class 2 and 3). This course includes “How to be a CRA” These can be ½ day to 2 days long depending on the depth of the details and whether it is interactive with workshops or a straight lecture.
Course for Sponsors or Investigator Sites for drug, biologics or medical device companies. It includes learning the tasks necessary to conduct a study properly and developing the skills to perform the tasks.
A one to two day course teaching how to optimize the activities of a clinical research center. Length of course depends on number of workshops Topics include GCP, personnel, finances, budgeting, marketing, etc.
Teaches the stages of development and how to get the product through clinical trials.
A presentation on what activities are needed and what requirements must be met to commercialize a product though FDA approval.
This course provides the knowledge for managing a project through clinical trials and the skills to be a project manager. It reviews people skills to be a good PM including communication styles and how to manage a diverse group. It includes the use of spreadsheets and MS Project to manage the project.
This course describes the development, approval and use of a consent form. It discusses common Sponsor and Investigator errors in these areas of informed consent and how to avoid them.
This course teaches how Sponsor Staff manage Investigator Sites. It discusses how to set expectations from the initiation visit and how to monitor the site for maximum performance. It also includes case studies and remedies for problem sites.
This course teaches how to design, writing and implement SOPS.
All courses can be customized for your specific needs. Contact us today at 585-318-1350 x246 to discuss training at your site!