Solutions for the life sciences industry require a highly complex development cycle. Each solution consists of the contributions of many role-players with multiple steps of validation and review. Managing clinical trials, tracking quality processes, and organizing regulatory submissions demand extreme attention to detail, accuracy and consistency.

EXTEDO’s eDOCSmanager consists of five modules to take projects from implementation to quality assurance. The Regulatory, Clinical eTMF, Site Monitoring, SOP and Quality modules work together with other EXTEDO solutions to provide a complete overview of projects and submissions. Some of the noteworthy features of eDOCSmanager include the ability to manage administrative and archiving tasks with drag and drop functionality, use templated forms and documents, automate workflows, and generate a complete record of activities.

“With eDOCSmanager, we now offer a complete RIM solution for life sciences organizations. Our customers can manage their projects from conception to completion using the comprehensive DMS solution to support their effortless compliance”, says Martin Schmid, Managing Director of EXTEDO.

eDOCSmanager promises to be a user-friendly, fully validated SaaS (Software as a Service) solution that can be implemented within days. As a cloud-based solution, the lower cost associated with the product substantially reduces deployment and operating costs while end-end data encryption guarantees security.

In addition to this, the seamless integration with EXTEDO’s submission management solutions ensure that the publishing process for any life sciences organisation is simplified, fast and effective. EXTEDO’s eDOCSmanager is compliant with FDA CFR 21 Part 11, ISO 27001 certified and validated following GAMP 5 guidelines. For more information on eDOCSmanager or the rest of EXTEDO’s products, contact EXTEDO today.

About eDOCSmanager

eDOCSmanager is a cloud-based DMS explicitly designed for the life sciences industry. It enables organizations to manage and monitor their projects and submissions while keeping all relevant information and data within a centralized location.

About eCTDmanager

eCTDmanager is an easy-to-use solution for building, viewing, validating, and publishing compliant submissions that meet global regulatory specifications.

About eSUBmanager

eSUBmanager provides a modern, end-to-end solution that improves the collaborative review process surrounding submission content and metadata in readiness for transmission to the publishing system.

The Taiwan FDA pre-announced the eCTD validation criteria on 16th June 2020 and will follow up this with a formal announcement after they have received feedback from the stakeholders within the Taiwanese medical industry.

The Genetics Generation Advancement Corporation (GGA Corporation), has partnered with EXTEDO to support the Taiwan FDA in their introduction of the eCTD standard within Taiwan.

Following countries such as the USA, EU, Japan, Australia, Canada and Switzerland, Taiwan will soon adopt the eCTD standard.

“EXTEDO is proud to support already more than 35 regulatory agencies globally reviewing eCTDs and other submission formats. We are excited to play a part in the introduction of eCTD in Taiwan and are honoured to support the needs of organizations within the country”, says Martin Schmid, Managing Director of EXTEDO.

Adoption of leading eCTD management solutions

EXTEDO’s submission management portfolio will bring effortless Taiwan eCTD compliance and enable the TFDA to review regional electronic submissions quickly and accurately.

The relevant EXTEDO submission management components are:

EURS, a software solution that serves as an overall eCTD validation and reviewing software tool used by more than 35 authorities worldwide. The enhanced EURS solution EURSnext, which Is selected by TFDA, is currently being implemented by more and more authorities globally.

eSUBmanager, the industry version of EURSnext, is used to manage, view, and review submissions. Using the same solution as most authorities provides confidence and reduced risk to the industry.

EURSvalidator, the leading electronic submission validation engine used by more than 35 regulatory authorities and thousands of users worldwide.

eCTDmanager, an easy-to-use solution to build, view, validate, and publish compliant submissions that meet global regulatory specifications.

About Genetics Generation Advancement Corporation

Genetics Generation Advancement Corporation (GGA), EXTEDO’s local partner in Taiwan does not only focus on delivering and implementing the end to end solution for Regulatory Information Management, but we are offering support, consulting, training and validation for local Taiwanese customers. Our clients have received great value with the EXTEDO solutions, they appreciate the user-friendly functionality which allows them to submit high quality submissions.

Today, EXTEDO’s and GGA’s strong collaborative partnership helps many customers to deliver compliant eCTD submissions effortlessly. We are proud to announce that we are assisting the Taiwan FDA (TFDA) to establish a submission management solution system, which will enable the automation of the submission, validation, and decision-making process.

Being a trusted EXTEDO partner, we have gained practical experiences, to enable us to provide consulting services for TFDA in the discussion of eCTD specification and validation criterion.

For more information, please visit www.gga.asia.

Wrike is an all-in-one collaborative work management solution that allows its users to manage workflows securely at scale, turn strategies into actionable plans and drive operational excellence.

Benefitting from the years of experience with hundreds of Wrike clients, EXTEDO adapted the proven collaborative project management solution to the requirements for pharmaceutical companies and  the life sciences industry, and integrated it with the EXTEDO RIM platform. This allows users to benefit from the project management solution experience of Wrike along with over 20 years of EXTEDO’s experience within the pharmaceutical industry.

“With the current global COVID-19 pandemic, it is more important than ever to provide life sciences organizations with a solution that allows them to bring their products to market faster and safer while being able to keep track on necessary changes globally” said Martin Schmid, CEO at EXTEDO. “We are glad that with Wrike, we were able to find the right partner to drive operational excellence and ensure effortless compliance in the life sciences industry.”

Wrike for life sciences is seamlessly integrated with EXTEDO’s regulatory information management solution and allows users to plan and track activities related to submissions, drug safety and product registration. Wrike is already used by the marketing departments of numerous pharmaceutical organizations for their promotional material, which is then later compiled within EXTEDO’s eCTDmanager.

“The COVID-19 pandemic is affecting and impacting every business across the globe,” said Aharon Weiner, VP of Business Development, Wrike. “Since the onset of COVID-19, we have seen an increasing demand for a regulatory solution based on our technology. With EXTEDO’s experts on hand, the joint solution combines the best of both worlds.”

About Wrike

Wrike is the most versatile work management platform for the enterprise. It can be easily configured for any team and any use case to transform how work gets done. Wrike’s feature-rich platform puts teams in control of their digital workflows, enabling them to focus on the most important work, maximize potential, and accelerate business growth. More than 20,000 customers, including Hootsuite, Tiffany & Co., and Ogilvy, and 2M+ users across 140 countries depend on Wrike to help teams plan, manage, and complete work at scale. Wrike is headquartered in San Jose, CA. For more information, visit: https://www.wrike.com/.