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Frances Sharpe

Guide to Clinical Trial Software

Clinical trials data management software increases efficiency for small and large studies


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Pharmaceutical, biotechnology, medical device and research organizations can all benefit from clinical trial software. Clinical trials data management software assists with all aspects of a trial - from enrollment to study submission to study archiving. Clinical trial software can be used for small Phase 1 trials or large studies with thousands of participants.

Benefits of clinical trial software include:

1. Clinical trials data management software can accelerate your study timeline and control costs without sacrificing the quality of study results.
2. Clinical trial software can ensure compliance with HIPAA, FDA regulatory guidelines, GCP, 21 CFR Part 11 and even with European regulatory guidelines.
3. With clinical trial applications, you can focus your efforts on your research rather than on study management.
4. Simplify patient recruitment and scheduling with clinical trial software.




Action Steps
The best contacts and resources to help you get it done

Compliance is no problem with clinical trial applications


Trying to keep up with all the various regulatory requirements for clinical trials can be a real headache. With clinical trial software, however, this laborious task is significantly easier to manage.

I recommend: DMSys is clinical trial software that is quick to learn and adheres to GCP and other regulatory compliance requirements. It provides the audit trail, documentation and compliance with 21 CFR Part 11, including electronic record keeping and electronic signatures.

Create budgets and cut costs with clinical trial software


With today's budget constraints, trimming costs is key for clinical studies. Clinical trial applications not only help you create a realistic budget for your study, they also reduce your costs thanks to improved productivity, which means it takes a shorter amount of time to complete the study.

I recommend: ClearTrial is clinical trial software that includes budgeting capabilities and can help reduce the costs of your study by up to 20 percent.

Choose clinical trial software that includes doctor and institution requirements


Recruiting, screening, scheduling and tracking patients is a major component of study management. Clinical trial applications can facilitate these tasks and should also assist you with the stringent requirements regarding doctors and institutions, including staff qualifications, previous experience and even potential problems.

I recommend: The Study Assistant from IMedRIS Data Corporation includes clinical trial applications that simplify patient, doctor and institution management to ensure your study meets all the requirements. MedNet Solutions offers clinical trial applications for all aspects of study management, including patient enrollment, withdrawals and honorariums. For additional tools to streamline patient recruitment for clinical drug trials, visit Business.com.

Learn the ins and outs of your clinical trial software


Like any software, clinical trial software takes time to implement and takes time to learn. Make sure you and anyone else on your study team gets proper training in using the software.

I recommend: Advanced Clinical Software provides a webinar and online training programs for StudyManager, its clinical trials data management software program.

Go online to use clinical trial software


Clinical trial software doesn't necessarily have to be downloaded onto your desktop computer. A number of web-based programs have emerged that allow you to access your study data via the Internet.

I recommend: ClinicalTrialsNet, Clinipace and OpenClinica are all web-based clinical trial applications that can be accessed from any computer anywhere as long as you have an Internet connection.

Tips & Tactics
Helpful advice for making the most of this Guide

  • Some clinical trial applications allow you to copy study set-ups and forms from previous trials to a new trial.
  • Look for security features in your clinical trial applications that allow the system administrator to set access privileges for each user and for each study.
  • Choose clinical trials data management software that integrates with other software programs, such as Microsoft Excel and other databases.
  • Opt for clinical trial software that can provide you with the status of all your ongoing studies on a single screen.

The official source of Clinical Trial Software is
the Clinical Trial Software page at Business.com

Featured Vendors

Clinical Trial Software
Compare Clinical Trial Software using Capterra's free, comprehensive directory.
Capterra.com

Coastal Carolina Research Center
Clinical Research Facility providing medical research, clinical trials, and investigational drug studies in Charleston, SC. Volunteers Wanted!
www.CoastalCarolinaResearch.com

Healthcare Research and Clinical Trials
Offers daily clinical trial updates and detailed information on drug pipelines.
www.biopharminsight.com

Health Economics Consulting Group
HECG provides research and expert consulting services in cost & outcomes studies, market & business analysis, and policy analysis.
www.HECG-LLC.com

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