DSG - Frequently Asked Questions

When did DSG succesfully deploys its first EDC clinical trial study?

Development of eCaseLink™ began in early 1998 in support of McNeil Consumer Pharmaceuticals. eCaseLink™ was released in beta form in 1999, and utilized in a clinical trial in early 2000. eDiaryLink™ ePRO (electronic patient reported outcomes) was also first utilized in a clinical trial in 2000. Today, all of our customers benefit from the technology advances that we can leverage and lessons learned from many deployments over the years.

Have you created all of your solutions, or have they been bought from other companies?

At DSG, we have created all of our solutions in-house; ongoing research and development, funded from profits generated by our current solutions, drive our future innovations and technology advances.

Many EDC Companies have come and gone in this industry-how are you different?

Since our inception, DSG strives to provide our clients with the most intuitive, comprehensive, customizable solutions at effective cost rates. Through this strategy, we have been able to grow 100% organically, and to be owned completely by our employees. All of our success has been attributed to our unwavering commitment to our customers and providing the most reliable solutions and services in the industry. We know that this has been the key to our success, and will continue to drive us into the future.

With regard to software applications, when was DSG's first tech transfer?

DSG completed its first tech transfer in 1994.

Is DSG a public or privately held company?

DSG has been a privately held, employee-owned, debt-free company for more than 20 years. Our revenues have increased every year since inception by more than 20%. If you'd like to get details on our revenue and profit growth, we would be happy to provide financials for as many years back as desired, upon request.

Is your system online or offline, or both?

eCaseLink™ is available in both online and offline versions. The online version (thin client) is web-based accessible via a secure internet connection. The offline version (thick client) allows for site coordinators to enter data into eCaseLink™ without an internet connection.

Does your system require client-side software?

Web access to eCaseLink™ requires that nothing needs to be installed by the client.

What technical requirements are necessary to get your system functioning?

Our system requires a link to the web via T1, DSL, cable modem or dial-up Internet service provider (ISP) access.

How long does it take to deploy a study?

Our timetable always depends on our customer's timeline, and with approved edit specifications.Recently, DSG implemented a study of 280 eCRFs, 30 unique pages. From final protocol to first patient in, total implementation time was 3 weeks. This is an example of the standard, not the exception.

Are your edit checks local or client-based?

DSG has developed proprietary technology that allows edits to occur against server data without submitting to the server. This offers several very important advantages:

  1. Fastest submission speed and zero page turn rate.
  2. Highest site acceptance: Screens identical to paper CRFs, making the transition the smoothest as possible, instant edits and zero-page turns.
  3. Less time spent entering data into the system.
  4. Minimal support calls: 90% of the support requested is simply re-setting a password.
  5. Nominal set-up time:Studies ready in less than 3 weeks, not 3 months.

What do you mean by "zero page-turn rate"?

DSG's technology is different than any other vendor in the industry. Our proprietary technology validates information field-by-field, instantly-without connecting to the server or requiring client plug-ins. This unique feature has been a main selling point of our technology since 1999. Errors are identified instantaneously-so when you save a page, you are saving a page of clean data.

Can you integrate with other systems?

Yes. DSG integrates with electronic patient diaries, IVRS, laboratory data, ECG and other third-party applications and databases. DSG has its own proprietary patient diary system, eDiaryLink™ that is fully integrated with eCaseLink™ EDC.

How long does it take to make changes to a study?

Mid-study changes are completed within hours of the request. The main issue about which sponsors have complained regarding other systems is with mid-study changes, where in other applications a small change may affect 75% of the eCRF. In eCaseLink™, changes made on one page, only affect one page, therefore programming, validation and testing is completed faster. This also controls the cost of these inevitable mid-study changes.

What are your reporting capabilities? What standard reports are available?

eCaseLink™ has numerous standard built-in reports and also robust ad hoc reporting capabilities. Over 40 standard reports are available, at no additional cost.

What are your reporting capabilities? What standard reports are available?

eCaseLink™ has numerous standard built-in reports and also robust ad hoc reporting capabilities. Over 40 standard reports are available, at no additional cost.

We have locations around the world. Can your help desk support us globally?

DSG's help desk is available 24 hours a day, 7 days a week, 365 days a year. DSG offers help desk support in over 80 languages. Talk to us about your needs and we can accommodate them.

Are you 21 CFR Part 11-compliant?

Yes. DSG's interpretation of 21 CFR Part 11 is conservative and expansive. 21 CFR Part 11 applies when using a computer system to create, modify, transfer or store an electronic representation of any information or process that is regulated by the Food and Drug Administration (FDA). DSG has completed an extensive analysis of its entire commercial application suite and the procedures utilized in the System Development Life Cycle (SDLC). DSG has satisfactorily met 21 CFR Part 11 requirements according to multiple auditing teams deployed by top pharmaceutical companies and contract research organizations with expertise in the system validation and compliance area. As 21 CFR Part 11 requires ongoing attention in order to maintain compliance, DSG employs personnel responsible for managing the dynamic nature of this regulation. Further, DSG understands that interpretations of 21 CFR Part 11 may differ from company to company and regards this as an opportunity to build its 21 CFR Part 11 compliance portfolio.

Have your studies been audited by the FDA?

Yes. References are available upon request.

Have your studies received FDA approval?

Yes. Several eCaseLink™ EDC studies have resulted in FDA approval, including several high profile drugs currently on the market, the first in early 2003. References are available upon request.

How many NDAs has your company been involved in?

To date, DSG's software applications have been used in 59 NDA submissions.

What security measures are in place to ensure that no unauthorized users have access to the system?

All of DSG's solutions offer multi-level password protection, secure log-in, data encryption and a secure server. eCaseLink™ EDC also comes with six standard user-access privilege levels and the ability to create customized user-access privileges. This allows our clients to assign the appropriate access level to each person involved in a study.