PURPOSEFUL CLINICAL TRIAL TRANSPARENCY INCREASES PUBLIC AND PATIENT TRUST IN CLINICAL RESEARCH SPONSORS AND MEDICINES.
Transparency & Disclosure Tip of the Day
Commercially Confidential Information (CCI ) is a term used in the US and EU for business sensitive information. Confidential Business Information (CBI) is the equivalent term used by Health Canada. Whilst sponsors tend to intermix these terms, the legal definitions do have some variations.
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Delivering purposeful and value added Clinical Trial Transparency Solutions
We are thought leaders in clinical trial transparency and data sharing with over a decade of consulting experience that includes project management and systems delivery. This combination of skills enable us to bring to life the right solutions for your business.
Process Optimization
Enhance efficiency and quality in your processes.
Ensure your processes meet the needs of regulators, researchers and patients.
Protect Patient Privacy and support secondary clinical research and enhance public health.
Policy Development
Anonymization Best Practices
Changing behaviors requires more than read and sign of your SOPs.
Training
Program Planning & Implementation
Connecting the dots with everything else changing for your teams will lead to successful implementation.
Patients
Ensure your patients understand the clinical research they are part of and feel appreciated for their contributions.


Quality Clinical Trial Transparency creates Trust with Patients, the Public, and Regulators.
We help our clients enhance processes, build policies, create and delivery training, and ensure compliance for clinical trial transparency and data sharing to meet the needs of the public, regulators, researchers and patients.




Process Optimization
We create policies and efficient processes that lead to quality outcomes and successful project delivery.
Patients, Researchers, Regulators and the Public
Transparency should provide value to the intended audiences. Do your policies meet end user needs?
Julie is a thought leader in the niche of clinical trial transparency. The trainings she provided are the highlight of my day. She made the topic interesting and easy to understand.
- client
★★★★★
Expertise
In addition to our speciality in CTT, we are experienced in business and IT program and project delivery. This uniquely positions us to successfully help clients design and adopt new regulatory and clinical processes and systems in the Health Care Insustry.
Consulting Services
Let's talk
julie@holtzopleconsulting.com
+12406264774
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