Products
EDC system
It can be challenging to collect and manage data produced in clinical studies; yet the success of a clinical research program relies heavily on the accuracy of the data captured. At Proclintek, we’ve developed a suite of EDC solutions to help our clients overcome the obstacles they face when collecting data, whether in single studies or in a portfolio of clinical trials.
Our eCRFs, developed through various EDC platforms, help sponsors achieve better results with their data, while improving their operational efficiency.
Consult us today to help you choose an EDC system that fits your needs and budget.
Learning management system
Although many organizations have adopted learning management systems for their internal training needs, many of these do not meet the threshold set by clinical trial regulatory requirements. Sites and study teams in a clinical trial need a centralized source for education and learning that is capable of administering and assessing clinical trial protocol curricula activities while providing certification.
Proclintek’s learning management system can help bridge the gap that sites and study teams encounter when it comes to education, learning, and knowledge assessments in a clinical research project.
If you need a learning management system to help you improve clinical trial outcomes consult an expert today.
Patient tools
For organizations to capitalize on technology solutions that streamline clinical workflows and deliver quality patient care they need innovative and responsive software that fits the bill. We have developed “ProclinTek Software”, a drug safety management tool that delivers a comprehensive and holistic solution for clinical and post marketing safety. It includes case management, report preparation, electronics submissions, and benefit & risk management in line with Pharmacology and national drug regulatory authorities in the US.
For your eConsent, ePRO/eCOA, Telehealth, patient portal, and home health visit solutions consult with an expert today.
Clinical trial management systems
To effectively manage clinical research trials, organizations need a clinical trial management system (CTMS) that serves as a single, centralized, web-based enterprise resource and is capable of running their core clinical, operational, and financial processes.
Proclintek provides secure, reliable, and scalable CTMS solutions with multi-center capabilities that help you carry out your core operations seamlessly while maximizing your IT investment.
Electronic Investigator Site File (Eisf)
Evaluation of the conduct of a study and the quality of the data produced are important for the successful outcome of the clinical trial. Investigator Site File (ISF) provides the proof that the clinical trial site and Investigator are adhering to the regulatory requirements established by the ICH GCP guidelines.
Proclintek’s electronic Investigator Site File (eISF) platform gives investigator sites running clinical trials full control over their investigator site files. It provides a cloud-based, secure, and convenient platform that meets regulatory requirements including system validation, digital archiving, audit trails and change controls.
In the dynamic world of clinical trials the need to store investigator site files electronically is becoming more critical for compliance purposes. Proclintek provides the platform to make this happen.
Electronic Trial Master File (eTMF)
Switching from paper TMF processes to an eTMF brings numerous benefits to all parties participating in a clinical study. By enabling sites to create or upload documents directly into the system, hours potentially spent printing, scanning and uploading documents are drastically reduced while saving on storage space in their facility.
Proclintek’s Eisf solutions help sponsors optimize systems, enabling them to shorten clinical trial timelines and fast-tracking their speed resulting in faster recuperation of their R&D investments.
eSource
Collecting and managing clinical trial data is becoming ever more reliant on digital platforms to increase speed and accuracy of the data capture process. eSource enables initial data capture to be done in real time, speeding up the capture process, while minimizing data duplication.
Proclintek’s eSource solution empowers your study staff to easily capture source data in the form of eConsent forms, ePatient diaries, and electronic case report forms (eCRF) optimizing clinical trial data management.
Looking for ways to reduce your data capture time and optimize study data management?