Clinical Site Certification - Clinics for Clinical Trials
1. Lack of training in clinical trials creating risk of negative FDA audits
2. Ignorance regarding the business aspects of running a clinical trials leading to loss of profits
3. Legal exposure due to unacceptable practices per the Sunshine Act
4. Need for help in negotiation and budgeting issues to assure fair pay
5. Limited resources to find new clinical trials suitable for their patients
FDAMap’s one-of-its-kind training offers a one-stop solution to the above and much more. FDAMap’s “Clinical Site Certification” program is like no other in the industry to train and certify clinical sites. Our experts will train you and your staff on all the latest industry practices, FDA requirements, best business practices to run successful clinical trials. You can train all your staff in the convenience of your clinic or a location of your preference. We also offer group training options for multi-clinic practices. Prior to the training, the trainer will work with you to add customized content to address any of your clinic-specific concerns.
Post-training support for finding suitable clinical trials, negotiating budgets, trouble-shooting FDA audits, and recruiting patients are also available. Your clinical site will act as an attractive hub for the clinical trial sponsors. We guarantee successful clinical trial business or money-back.
The training complies with FDA’s recommendations per the CTTI.
For more info, fill the box below. We will contact you within 24 hrs.
6 Modules/Webinar Sessions:
- Good Clinical Practices and Compliance Issues: Practical GCP
- Risk Management in Clinical Trials for Physicians: FDA audits, client inspections, troubleshooting
- Recruitment Issues in Clinical Trials – Advertising, Data-mining, Referrals and Social Media Practices
- Compliance with Sunshine Act for Clinical Investigators
- How to Withstand an FDA Audit of Your Site
- Clinical Trial Budget, Invoice, Contracts, and other Practical Issues
Areas/Topics Covered in Clinical Site FDA-Compliant Training
- Responsibilities of the Investigator and the site staff per FDA
- SOPs needed for a clinical site
- GCP and Good documentation practices
- Best practices for patient recruitment & Retention
- Best business practices for dealing with sponsors
- Best practices for social media usage by doctors and staff
- IRBs, Informed Consent, Confidentiality and Privacy
- Social media strategies to handle patient recruitment
- Sunshine act, HIPAA and Hitech Rules for Clinical
- Customized content per your specific needs and concerns
For more info, fill the box below. We will contact you within 24 hrs.
Following are the key benefits of “Clinical Site Training cum Certification Program”.
- Customized training to address clinic-specific concerns
- Flexibility to choose training location and group training
- Understand latest FDA requirements for clinical site audit
- Training complies with FDA’s recommendations per the CTTI
- Training to deal with FDA Inspectors confidently while they visit your site
- Clinical Site Training Certificate with 3 Years of validity
- Making site an attractive hub for clinical trial sponsors
For more info, fill the box below. We will contact you within 24 hrs.
Dr. Mukesh Kumar, PhD, RAC
Lead Consultant, Regulatory Affairs and Quality Assurance
Brij Strategic Consultations (FDAMap.com)
Dr. Mukesh Kumar is a Washington DC-based consultant in regulatory affairs and quality assurance for manufacturers and developers of pharma and biotech products. He has been involved in more than 100 multi-national clinical trials, has made hundreds of submissions to the US FDA, EMA, and regulators in more than 40 countries. He has arranged a number of meetings with the US FDA. He has created and led numerous teams for development of pharmaceutical, biotech and medical device products all the way from early stage development to commercial markets. He has conducted GCP, GLP, GMP and GACP audits in the US and several countries in Europe, South America and Asia. He has conducted hundreds of training workshops and has authored numerous peer-reviewed high impact articles on healthcare regulations. He authors a popular Weekly Newsletter on FDA related issues read by more than 100,000 readers worldwide. He is a frequent consultant to investment companies, government policy think-tanks, social media enterprises, and international business corporations. He is a well known expert in global regulatory affairs and has been an invited speaker at several professional and academic organizations worldwide. He is a visiting professor at George Washington University, Washington DC, and Montgomery College, Maryland. Dr Kumar is PhD in Biochemistry and is a certified regulatory affairs professional by the Regulatory Affairs Professional Society, USA.
For more info, fill the box below. We will contact you within 24 hrs.
Registration (Clinical Site Certification Training)
Specific Webinar/Sessions:
You can register for any one or combination of the following webinars
Good Clinical Practices and Compliance Issues: Practical GCP
$349
Risk Management in Clinical Trials for Physicians
$349
Recruitment Issues in Clinical Trials
$349
Compliance with Sunshine Act for Clinical Investigators
$349
How to Withstand an FDA Audit of Your Site
$349
Clinical Trial Budget, Invoice, Contracts, and other Practical Issues
$349
Prices are in US Dollars.
The registration fee includes the workshop and all related course materials.
Terms & Conditions to register for the Workshop
Your Registration for the workshop is subject to following terms and conditions. If you need any clarification before registering for this seminar, please email us at info@fdamap.com
Payment:
We accept credit card, debit card, and PayPal.
Cancellations and Substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 20 working days prior to the start date of the event will receive a refund — less a $200 administration fee per person. No cancellations will be accepted — nor refunds issued — within 20 working days from the start date of the event.
On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($200) will be transferred to any future FDA Map event and a credit note will be issued.
