The clinical protocol is the foundation of every clinical research study. It is also the catalyst for a $500 million spend on information - required documents, forms, submissions and public data disclosures. Structured Protocol Authoring will not only help reduce the cost of protocol development, it will improve compliance and significantly reduce the cost to produce all “downstream” information that is dependent on the protocol document. Savings utilizing Structured Protocols and other structured documents could be 30-40%.
Sylogent is a key partner responsible for Protocol Registration and Clinical Trial Data Disclosure to such portals as clinicaltrials.gov and EudraCT. Since the company also provides Publication Planning software and services it understands the importance of publishing consistent data within limited timelines. ePROTOCOL is another solution designed to simplify complex timelines, documents and processes. The benefits for Structure Protocol Authoring are numerous including:
With ePROTOCOL we are able to design unlimited structured templates that share reusable data. These integrated templates allow for original source data to be easily reused in downstream documents thus reducing resource workload, eliminating data entry errors and minimizing document approval timelines.
ePROTOCOL can be configured to import data from your Word or Excel Templates. With the push of a button, the system can automatically create over 300 integrated structured templates including: Study Master Form, Clinical Study Report Template, EU & US Protocol Registration Forms, Publications Study Form and more.
Configurable Protocol Templates
Integrated Child Templates
Process & Project Tracking
Budget & Spend Tracking
We realize that Structured Protocol Authoring is a significant change for most pharmaceutical, biotech or device companies. It can impact many stakeholders across the organization. That is why ePROTOCOL is more that just software, but will require process and change management services to ensure success and to maximize enterprise value.
Please contact us today if you are interested in learning more about how ePROTOCOL can help your organization stay compliant, achieve submission timelines and ensure public data consistency.
Reduced regulatory planning complexity
Improve compliance adherence
Increase data consistency
Improve document comparing
Automate downstream document creation
Increase clinical development efficiency
Improve study data quality
Maximize public data consistency
Data & Template Stewards