Apeleex Suite
Gaining insights in clinical trials
With Apeleex Suite，we present an accurate, stable, and easy-to-use data platform with improved operation efficacy and secured data competency.
With Apeleex Suite，we present an accurate, stable, and easy-to-use data platform with improved operation efficacy and secured data competency.
Every day, patients are waiting for new drugs being discovered. Drug development and clinical trials are sophisticated processes to discover new drugs and prove their safety and efficacy. During this process, Apeleex focuses on the trial protocol, data, and documents. By leveraging the innovative software technology, Apeleex helps biotech to investigate critical protocols and data, and make the process a smooth journey.
Biotech firms’ data journey requires a data platform that is an accurate data ecosystem. Starting from protocol design, and continuing through planning, execution, analysis and submission, every piece of information must be treated accurately.
The biotech must focus on its own valuable and creative work, in order to remain competitive in the industry. Leave the system design work to computer and AI software developers like Apeleex.
Digitalization of clinical trial includes protocols, data and documents, such as:
Protocol
EDC dataset
PK/PD data
Testing Lab data
PV data
TMF document
Submission document
others
Data application is changing the traditional way of conducting clinical trials and improving efficiency.
For example, data application speeds up the recruitment of patients and improves economic feasibility. Data application also eases the burden of data monitoring and reviewing –SDV (Source Data Verification）is usually time consuming, costly, and error prone; and FDA guidelines encourage the centralized monitoring as part of RBM (Risk Based Monitoring) together with the site monitoring.
Apeleex Suite is a model driven data platform. The underlying technology is a data security and transformation engine. The data platform now consists of three software: eTDM（Trial Design Management）, eDRM（Data Review Management）and eTMF（Trial Master File）.
eTDM（Trial Design Management）is used in the protocol design, with the main functionalities including protocol management, library management, and template management. eDTM help the protocol designers to automatically process the duplicative tasks, so that they can focus on the critical tasks, and the software helps protocol reviewers to quickly compare the different versions, finish the automatic verification, and thus improve the design quality and efficiency.
eDRM（Data Review Management）is used in the data reviewing process to help data reviewers with all the data and to flag any issues. The main functionalities include data synch, patients profiling, trial operation efficiency, trial safety and efficacy, and narrative automation. The software allows users to easily retrieve the data accurately and use it from different perspectives, whether it is for operation, data integration, or analysis – all in accurate and quick ways.
eTMF（Trial Matser File）is for document management, and its main functionalities include document management, version management and auditing. eTMF helps manage the documents and make this process safe and timely, along with avoiding other document management quality risks.
The Apeleex team is a small group of passionate and creative software architects and developers. Working with biotech experts, we are making Apeleex Suite a powerful data platform and deliver data value to our users. Apeleex is devoted to be the “Leader in Pharma Digitalization”, and dedicated in servicing more biotech firms in the world.
If you are biotech or biopharma looking for an innovative and easy to use data platform for your company, please contact Apeleex. We provide Apeleex Suite and can customize to your specific needs. We are dedicated to serving your needs.
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