Holtzople Consulting

We are clinical trial transparency and data sharing thought leaders. We are program and project delivery experts. We are process optimization experts who can train and support the change necessary to implement the optimized processes. Let us help you become more efficient, saving resources and delivering quality results. We have proven results in all of the above areas. Examples include: - Create or enhance your processes to ensure they are driving efficiencies and quality in your organization. - Build Company Policies around Clinical Regulatory Deliveries such as Clinical Data Sharing, publication of patient Plain Language Summaries, etc. - Develop Anonymization Rules and practices your internal teams can use to prepare Policy 0070, HC PRCI, EU CTR and other submission ready transparency documents. - Resolve process challenges and daily issues arising from a complex portfolio, process challenges, audits or more. - Provide Training on new processes and policies to ensure your staff are ready and able to be success. - Establish metrics and KPIs for processes and deliverables. Enable measurement and tracking. - Design effective program delivery for connected projects to enable successful and timely deliver. - Ensure IT projects are designed and built to meet actual business need.