Structured Protocol Authoring

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%.

We can help!

Sylogent is a key partner responsible for Protocol Registration and Clinical Trial Data Disclosure to such portals as 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:

software software

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

Automated Planning

Process & Project Tracking

Milestone Management

Budget & Spend Tracking

Resource Forecasting

services services

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

Process Evaluation

Change Control

Data Dictionary

Milestone Management

Data & Template Stewards

Compliance Planning

let's talk!

reduce costs!

Trusted Resource since 2002

let's talk!