FGK's ePRO

FGK CRO has leveraged the ePRO software Viedoc Me to improve the efficiency and quality of its clinical trials. The software provides several benefits, including:

Viedoc Me facilitates the use of electronic diaries, which improves patient compliance by providing reminders and easy access to the ePRO platform. Participants can effortlessly record their symptoms and severity, helping to ensure that measurement of these is accurate. This method enhances the feasibility of data collection and ensures higher quality records.

The feasibility of implementing ePRO software in clinical trials is significantly higher than traditional methods. The user-friendly interface of the software makes it easier for participants to adhere to reporting requirements – in contrast to traditional paper diaries. This compliance is crucial for ensuring the validity of the clinical trial results. The software also allows for better communication between researchers and participants, enhancing the overall research experience.

Robust EDC capabilities allow for seamless integration of patient-reported data which streamlines the process of data analysis and reduces the chances of errors that are common with manual data entry. ePRO software improves the measurement of patient-reported outcomes by providing more accurate and timely data. Traditional paper diaries often suffer from issues such as backfilling, where participants record multiple entries at once, compromising data quality. In contrast, electronic diaries ensure that entries are made in real-time, enhancing the validity and reliability of the data collected.

ePRO systems adhere to international standards for data security and privacy. This compliance is vital for the validity of clinical trial results and their acceptance by regulatory bodies and though it can be achieved by traditional methods such as paper diaries as well, electronic methods enhance efficiency by CROs in this regard.

The accurate measurement and timely collection of patient-reported outcomes leads to better medical monitoring. Researchers can quickly identify adverse events including severity or trends in responses, allowing for swift intervention and improved medical care.

The adoption of ePRO systems enhances research methods by providing more flexible and patient-centric approaches to data collection. This flexibility allows for the collection of more nuanced data, which can lead to a deeper understanding of patient experiences and treatment feasibility.

Below are some specific types of trials and detailed indication examples where electronic patient-reported outcome measures (ePRO) is particularly advantageous:

Pain Management Trials

Indication Examples:

• Fibromyalgia
• Migraine

Benefits:

1. Real-time Pain Reporting: Patients can log pain levels and pain relief in real-time, providing accurate data on the severity of pain and effectiveness of pain management strategies.

2. Medication Use: ePRO helps track medication use and side effects, ensuring accurate reporting of analgesic consumption and its effects.

3. Daily Impact: Detailed diaries can capture the impact of pain on daily activities and overall well-being, offering a comprehensive view of treatment outcomes.

The development of ePRO software has revolutionized the clinical trial landscape by improving the measurement, feasibility, validity and overall efficiency of data collection. FGK CRO’s positive experience with Viedoc Me highlights the numerous benefits, including better compliance, data quality, validity and participant experience. As the adoption of ePRO continues to grow, further advancements in data collection methods will lead to even more reliable and valid outcomes in medical research.

Find out more: All of FGK’s eSolutions

For more information on our ePRO contact FGK today.