Document Redaction and EU Policies

Meeting Global Registry Requirements

Have a new clinical trial about to begin enrollment? Has one just completed? The clock has started! With global registries on the rise and registration complaince increasingly in the spotlight it's hard to know where to begin improving on, supporting, or even starting your disclosure process.

There are many paths to successful compliance but the key to reaching your goal efficiently and effectively is having experienced people to guide you through the process. 
Redaction, anonymization, data sharing... what does it all mean and how do you ensure you are doing what you need to in order to meet the requirements?

Our rigorous redaction process supported by adaptive search technology means you can feel confident in the quality of the finished document.

If you struggle with supporting your data sharing requests, our robust online tracking solutions help you organize and plan. 

Services

Disclosure

Online Tracking

Document Redaction

Registration and results disclosure services to meet European, US and international regulatory requirements
Easy to use platforms for tracking disclosure and data sharing projects with dashboards, metrics and more
Clinical document redaction and intelligent automation

SAS / XML

Medical Writing

Pharmacovigilance

SOP and clinical document writing including Technical and Lay Summaries of Trial Results 
SAS programming and XML transformation to support disclosure and transparency efforts
Market Research and Patient Support Program, Pharmacovigilance process consulting and tracking technology

Management Consulting

Regulatory guidance, Process building, documentation development, training for internal teams and more