Clinical Trials Management

Elinext developed a modular software platform that allows life sciences companies to streamline the execution and commercialization of global clinical trials and collaborate on partnerships while reducing administrative burdens.

Challenges

Before addressing Elinext, the company used an outdated solution based on Domino platform and an old ExtJS version. The application was completely refactored to use modern Origami platform with the latest ExtJS version.

The main purpose of the system was to simplify the tasks associated with document management.

Our solution

Since 2010 till now, Elinext team has been developing the fully-functional SaaS platform for clinical trials management and collaboration with the configurable modular interface and securely host files in a 21 CFR Part 11 Compliant centralized virtual data room.

In the course of work, the team worked on the following modules:

Super Admin panel (for support engineers – can be outsourced to client pharmaceutical company):

  • high-level instance configuration;
  • enable/disable modules.

Study-level admin panel (for support engineers, access can be granted to client reps):

  • general settings;
  • Users & Groups management;
  • configuration for document Security;
  • Workflow configuration;
  • document management configuration;
  • eTMF studies configuration;
  • Reports configuration;
  • Investigative sites configuration;
  • Study Start-up configuration.

Client accounts: (labs, clinics, doctors, external pharma auditors in clinical research)

  • document management;
  • metadata coding;
  • reports & dashboards;
  • task management;
  • audit;
  • communication;
  • Q&A;
  • FAQ.

What is more, the team has implemented all dashboards and metrics to review how clinical trials are held with charts, graphs and diagrams. Using a report module, one can audit any action for the particular study.

Multiple documents can be imported at the same time using Windows archives – before, it was done one by one. Also, one can export documents to an archive or export documents’ metadata to HTML, EXCEL or WORD files.

To meet standards of the high quality in the pharmaceutical industry, our team set up QA process from scratch, implemented Agile development methodologies, manual, automated and load testing. All in all, there were over 5 000 manual tests and 2 100 automated tests performed, over 5 000 defects were found and documented.

The system is deployed on 150 servers and has over 50 000 users. Testing documentation preparation and auditing comply with 21 CFR Part 11 guidelines.

Specific features

  • Document security management with electronic signature – every user with appropriate rights can review the document with some restrictions to save, copy and etc. and sign if required.
  • Automatic recognition of a document type.
  • Modules migration from ExtJS-based solution to Angular.
  • A lot of third-party modules integration: IRB/EC using APIs, eSignature, Alfresco, Sharepoint, DocuSign, Adlib, PleaseReview, AbobeSign, Seclore, Snowbound viewer, ARender viewer, Prizm viewer.
  • Extensive integration with a totally new CMS system Alfresco saving all the features and benefits.

Business benefits

The outcome of the project is a robust SaaS solution with a completely new architecture. The solutions are used by pharmaceutical, biotechnology, and medical device companies, as well as CROs, IRBs/ECs, and leading academic institutions involved in clinical development.

Elinext engineers keep adding new features into the system to meet all high clinical trial standards.

SCREENSHOTS

home_page
dashboard
settings
SSU
document management
reports

INFORMATION

Region: USA

Industry: Pharmaceutical, Healthcare

Type: Web

Engagement model: Dedicated team

Duration: 2010 - till now

Staff: 20 people

Platforms: Web