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Phase IV Trials, Keys to Success

Phase IV Trials, Keys to success

PCG Clinical Services has a strong and meaningful track record with Phase IV trials. We know the challenges and have gathered the keys to success. Read to learn more about how we can use our in-depth knowledge to help you plan and design your trial in the best possible way. Not only do we have the experience but we are the official Master Viedoc Users which means that we have the most clinical trials conducted using Viedoc. For the end user, this is good because it boils down to shorter setup times and less cost. 

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KEYS TO SUCCESS IN A PHASE IV TRIAL

Collecting accurate data while making it as easy as possible for site staff is crucial. A user-friendly system is essential to site staff because their time to enter data in the eCRF is very limited. With many functions directly built into the eCRF system, Viedoc can avoid poor quality data and many of the common quality issues and pitfalls in phase IV trials.

• A smart CRF with only the must-have data elements and appropriate data cleaning strategies

• Critical variables clearly identified

• The CRF should be designed to ensure that maximum data cleaning activity can be achieved at the time of data entry into the EDC platform

• Easy to understand query text & avoid complex edit checks

• SAE occurrences are monitored on an ongoing basis

• Ongoing reporting/metrics analysis to identify error trends

• Data consistency checks; comparison across sites and over time often uncovers systemic issues that would otherwise go unnoticed

• Maximizing data collection via drop-down menus and radio button options

• Cleaning majority of the data utilizing real-time, front-end edit checks and less dependence on manual listings

• Epidemiology and Biostatistics teams to be involved from the beginning of the eCRF build and validation

• Health economy modules

While ensuring ease of data entry, Viedoc also provides an equally mission-critical success factor to any Phase IV study – ease of data retrieval. Viedoc offers on-demand data retrieval via data display graphics or downloaded as a PDF, Office Open XML, CSV, CDISC Open XML. The ease of data retrieval enables Sponsors to provide evidence-based communication to multiple parties in the format required at the stroke of a key.

CHALLENGES IN A PHASE IV TRIAL

A phase IV trial has many challenges. One considerable challenge is the production of poor-quality data. Mediocre quality data is caused by empty fields with missing data in the eCRF, query resolution turnaround times and the need for precise responses to queries. Additionally, it is common with limited knowledge of safety reporting requirements and this often leads to under or over reporting of Serious Adverse Events.

DISCOVER THE PCG DIFFERENCE WITH A FEW CLICKS

As Viedoc Master Users we bring you the power of this cutting-edge, easy-to-use EDC system to pharma, medtech, and biotech companies across the globe. We want to change the way you conduct clinical trials by bringing more efficiency, usability, and flexibility to your EDC. Viedoc provides multiple perspectives of your study through study, country or site level views to help in early identification of risk. Contact us and we will lead you through the process of setting up your next study to ensure you ask the right questions up-front, capture and structure the right data, convert information to knowledge through effective analysis, and empower you to make evidence-based decisions while saving time, money, and ultimately lives.

Benefits at a glance:

• 75% reduced study set up time

• Less cost for overall EDC system setup

• Limited training required

• Flexible, intuitive and fun to use

• Study database for multiple studies

• Ease of statistical retrieval

• Up to date metrics, accessible at all times

• Missing data reports & query aging reports

• Quick & easy access to the presentation of data

• All issues in one listing for quick action

• Maximized data quality

• Enhanced monitoring efficiency

Viedoc™

With Viedoc you don’t have to worry about platform availability, maintenance, and backups. A web browser is all that’s required to access the full functionality of Viedoc. The Viedoc platform consists of several applications and thousands of features that can be turned on or off in a specific trial. With this rich variety of possibilities, the platform is ready to take on any kind of trial in any phase. Health economic analysis can be performed through the build in health economic modeling.

ViedocMe™ is an ePRO module (electronic patient reported outcomes) that lets your subjects report data via their smart-phones, tablets, or computer – ViedocMe runs on any device with a browser. You can set up automatic reminders via SMS or e-mail to make sure you collect the relevant data within the designated time frame. ViedocMe is eliminating both the need for data entry by site staff and potential transcription errors, by collecting data directly from the source.

Viedoc is CDISC compliant which makes dataset (e.g SDTM) programming and creation very efficient.

 

Contact us to learn more.

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