On August 2017, MedProve presented its first electronic data capture (EDC) system or clinical data management system (CDMS) CheckPad that is tailor-made for a Southeast Asian market. Complying with FDA, EMA and ICH standards and integrating multiple functions, CheckPad is expected to become a leading solution for clinical trials in the area.
Despite its long-term presence in North America and Europe with an estimated global spending of $40 billion in 2016, ‘clinical trial’ is still somewhat a foreign term to ASEAN countries. However, considering the upward trend of non-communicable diseases such as diabetes and cancer in this region, it is vital that new and effective medications and therapies are put into use. In other words, clinical trials are to witness a boom in quantity here in the next decade, signaled by an increase of 573 trials from 2016 to 2017.
In answer to the increasing demand for shorter study duration and lower cost, eClinical has transformed from a combination of technological tools for clinical research into a business process. This market scored at $3.3 billion revenue in 2015 and is forecast to reach $12.8 billion in 2024 on a global scale. Yet, eClincial hasn’t left many footprints in Southeast Asia, as studies conducted here are still largely dependent on traditional methods of collecting and managing data due to a tight budget.
“With product development team based in Southeast Asia, we deeply understand the desire for data integrity at a reasonable cost,” said Hieu Dao, CEO of MedProve. “CheckPad provides low-budgeted trials with world-class services at a price they can afford.”
The software includes multiple functions to guarantee a global-quality solution to clinical data management:
- Study and Site Management: Users can operate multiple sites and studies at a time without the risk of mixing data normally found in the paperwork and spreadsheet approach.
- Subject Management: With a vibrant color-coding and symbol system, researchers can easily keep track of patients’ statuses.
- Data Entry with eCRF: Rather than writing down information on a traditional case report form (CRF), an electronic version is integrated into the software so that once keyed in, data will be automatically generated into a spreadsheet form stored within the system.
- Batch Actions: Users save a great deal of time with one-click-serves-all function.
- Source Data Verification (SDV) Management: Investigators and data managers can always log in and double-check the sources of data entered.
- Discrepancy Management: First, researchers can set up edit checks as possible ranges for data values, so that when something that doesn’t feel right come up, the system will push a notification. Second, when checking data, an authorized personnel can create a query if he or she is unsure about the data generated. This feature gives way to the integrity of data before analysis.
- Audit Trail: All actions are recorded with specifics of who did what so that no confusion can come into sight.
- Export Dataset: Once checked and locked, data can be exported into reports with globally standardized templates.
- Customizability: MedProve offers customizations in accordance with clients’ requests in order to maximize study effectiveness.
“Our vision is to support healthcare industry by becoming a pioneer and leading eClinical solution provider in Southeast Asia. In trying to improve the efficiency of clinical trials, we hope to get new medications and therapies to the hand of those who need them most,” continued Mr. Hieu. “We’re not stopping with CheckPad. Our team is working to develop a full package including electronic patient-reported form (ePRO) and randomization all in one cloud-based platform.”
Talking about MedProve, Mr. Hieu affirms: “We are founded based on one value of Trust. We treat our clients’ problem as our own with a hope of growing together. Investing in people and focusing on customers are our brand’s commitments.”
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