Common GCP violations such as protocol nonconformity, insufficient/inaccurate data, poor drug accountability, informed consent miscues, and adverse event reporting can warrant the FDA to deliver a warning letter to the site investigator.
Some Questions to Consider when Preparing for Inspections:
- Is the study meeting GCP standards?
- Is the collected data reflecting the occurrences?
- Are all relevant IRB deliverables being met?
- Are the standard operating procedures in use?
- Are protocol deviations being properly monitored and documents?
- Is the site being monitored properly and communicating with the study sponsor?
In August, The Clinical Trial Inspection Readiness Summit will provide seasoned industry experts discussing insights and best practices for preparing and conducting a site inspection.
| Join these companies in attendance: |
- Allergen
- Amarin Corporation
- Array BioPharma
- Boehringer Ingelheim
- Boston Scientific
- Bristol-Myers Squibb
- Cephalon
- Cleveland Clinic
- Cordis
- Daiichi Sankyo
- Genentech
- Genomic Health
- GlaxoSmithKline
|
- ImClone
- Johnson & Johnson
- Janssen
- Merck
- Merck Sharpe & Dohme
- Millenium
- MitsubishiTanable
- Novartis
- Pfizer
- Shire
- Stryker
- Takeda
- Tarsa Therapeutics
|
CUSTOMIZE YOUR EXPERIENCE WITH ALL ACCESS!
35+ INDUSTRY-LED EDUCATIONAL SESSIONS
3 PRE-CONFERENCE WORKSHOP CHOICES
125+ CLINICAL EXECUTIVES TO NETWORK ALONGSIDE WITH
$0 IN EXTRA COSTS |
The inaugural Clinical Trials Inspection Readiness Conference will be co-located with ExL's eClinical Trial Management and Leveraging EHR within Drug Development events providing a "one-stop information resource" to clinical research professionals to network, learn and bring solution-driven data to their respective organizations. Pick the sessions that fit your responsibilities and get more value for less!
| For more information on available sponsoring and exhibiting opportunities, please contact Mark Coulter at 917-258-5140 or mcoulter@exlpharma.com |
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