Opko Health Inc (OPK)

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DSG and OPKO Health Enter into Enterprise Licensing Agreement for Fully Integrated EDC, IWRS, Safety, and Trial Management Solution ( http://www.businesswire.com/news/home/20141104006106/en/DSG-OPKO-Health-Enter-Enterprise-Licensing-Agreement#.VFkyF_3wuUk )

OPKO Health to build and configure integrated data capture and drug safety systems

November 04, 2014 10:14 AM Eastern Standard Time
MALVERN, Pa.,--(BUSINESS WIRE)--OPKO Health, Inc., a multinational pharmaceutical & diagnostics company, has selected DSG’s eCaseLink integrated suite for self-building of harmonized electronic data capture (EDC), IWRS, drug safety event capture and case reporting, and CTMS systems. DSG’s team will support the OPKO team and their Site users 24 x 365.

“We are very pleased to be working with OPKO Health”

DSG’s Drug Safety, a comprehensive adverse event management system developed by DSG as part of an integrated suite including EDC, IWRS, and CTMS, streamlines the safety recording, reporting process, data entry on Serious Adverse Events (SAEs), storing associated documents facilitating the generation and tracking of queries. Features include integration with other regulatory and management systems, ICH E2B compliance, and generating FDA 3500A MedWatch and CIOMS forms, exporting data as required. Sponsors configure the system to accommodate unique workflows and procedures more efficiently.

DSG’s flagship EDC software, eCaseLink™, in continuous use since 1999, provides system builders with an intuitive tool, DSG Designer, enabling unlimited quantities of cross-visit edits on eCRFs without compromising system performance, a proprietary technology unique to DSG. Other helpful features include risk-based monitoring, 3rd-party system data integration, module for managing local lab Normals, integrated MedDRA/WHO drug auto-interactive encoder, ad-hoc reporting, SAS datasets on demand, patient profiles, protocol deviations, image upload and management, unlimited auto-emails, auto-population between eCRFs, Innovation Award-winning IWRS and also Data Management dashboard, integrated training modules, with round-the-clock support from DSG, one of the industry’s oldest and most experienced EDC providers.

“We are very pleased to be working with OPKO Health,” said Tony Varano, CEO of DSG, Inc., “and are excited to partner with and support such an experienced and talented multinational team with our technology.”

About DSG

DSG, Inc. supports clinical data capture and management with a proprietary, organically integrated suite of award-winning user-friendly technology solutions, including flagship eCaseLink™ EDC, ePRO, IWRS, Drug Safety, and CTMS. Since 1992, DSG has successfully supported thousands of clinical trials for over 400 companies and 25,000 sites across 90 countries, headquartered in Malvern, Pa., with additional offices in the U.S. and Asia: www.dsg-us.com ( http://www.dsg-us.com/ ) .
All products and services above are the property of their respective owners.

Contacts

DSG, Inc.
Jack Minster, [phone]
[e-mail]

Uncle’s DD Note#

DSG Inc. ( http://www.dsg-us.com/about_history.aspx?menuclicked=About ) (Document Solutions Group) is the oldest and most trusted provider of EDC solutions in the industry. Our roots run deep in clinical trials. Since our founding in 1992, DSG has produced the most innovative software solutions for the pharmaceutical, medical device and life sciences industries world wide.

Our corporation, software and services have grown through our understanding of technology and our collaborative approach with our clients. In our beginning, and before the internet became mainstream, DSG pioneered CRF document management software, setting an industry standard. Our best-of-breed CaseLink allowed individuals to build CRFs electronically, greatly reducing the amount of time it takes to run a clinical trial. CaseLink became the industry standard, and has been trusted and utilized world-wide by the top 5 pharmaceutical companies since 1992.

DSG continues to lead the way in the clinical trials software arena with eCaseLink EDC, Data Management services and CTMS.

eCaseLink™ EDC ( http://www.dsg-us.com/eCaseLinkEDC.aspx?menuclicked=Products )

eCaselink EDC Delivers Streamlined Studies, Clean Data, and Results.

The premier EDC clinical trial software, eCaseLink™ combines novel technology and unmatched industry experience to help reduce clinical trial time, improve accuracy, drive down costs/improve ROI, prevent risk, and use clinical trial data more effectively.

The most successful clinical trials begin and end with the highest quality, clean data. Data that is collected in the most streamlined and efficient way possible. An Electronic Data Capture (EDC) system is a computerized system designed for the collection of trial data in a electronic format for use in human clinical trials. EDC Clinical trial studies are accomplished with the best clinical trial software, eCaseLink™.

DSG’s award-winning eCaseLink software is the most advanced EDC solution in the industry. eCaseLink 8.2 is a truly integrated eClinical solution that seamlessly combines CTMS, EDC, IWRS and Safety into a single system, cutting costs and giving you control over your entire study. Unlike other systems that attempt to force completely unrelated systems to work together, eCaseLink was developed from the ground up as a truly integrated system whose parts work effectively as a whole. eCaseLink helps you to see everything that’s happening with your study in real time, at all times. This unmatched level of control helps you to make mid-study changes, contain costs, improve safety and increase ROI.

eCaseLink provides the fastest start up, rapid database lock, and more rapid FDA submissions, resulting in a greater ROI. eCaseLink features cross-panel edit checks that fire instantly upon data entry, eliminating trial delays and need for time consuming server calls, making it easier for your users to move through their data entry.

DSG's clinical trial software technology eCaseLink, is a unique proprietary, user friendly-interface. eCaseLink sends instant data validation accelerating data collection and ensuring consistent, high quality data in real time.

eClinDirect CTMS (Clinical Trial Management System)

eClinDirect, DSG’s web-based Clinical Trial Management System (CTMS), is a project management application that helps you to capture and share a wide variety of clinical trial project status information across multiple studies. eClinDirect gives you unparalleled control over your study.

Advanced reporting functionality provides easy access to metrics, workflow events, action items, documents collected and protocol deviations. Providing a detailed view of your entire study in real time, at all times.

The CTMS Challenge

Tracking progress at Investigator sites via paper visit monitoring trip reports is time consuming and delays access to critical status information about how the Study is proceeding. DSG offers a web-based Clinical Trial Management System application. Accessible anywhere in the world via an Internet connection, ClinDirect provides a centralized database for sharing clinical trial information. Information about the sponsor, protocol, and investigators, and CRA monitoring visit reports are also available online, in real-time. Role-based security provides various levels of access control. An e-Signature function facilitates the electronic workflow of the visit monitoring forms.

The CTMS Solution

Investigator visit monitoring reports should be entered into a relational database, making their content available to any user anywhere in the world with an Internet connection and the proper security credentials. Reports can be generated in real-time, showing the planned-versus-actual status of monitoring activities and exposing protocol deviation and adverse event reporting issues in a timely manner.

DSG’s unique approach validates that the online visit monitoring form questionnaire is filled out completely; that comments exist for questions with negative answers. The online form is then routed via electronic workflow using an e-Signature design. E-mail notifications are available, and all actions write to an Audit Trail.

DSG’s CTMS solution makes the content of the monitoring visit forms available online, in real-time for review by members of the project team. Advanced reporting functions provide easy access to metrics, workflow events, action items, documents collected, and protocol deviations.

ClinDirect is configurable. The configuration process begins with a discussion of the desired access control levels and electronic workflow of the monitoring visit reports. The online monitoring visit report form questionnaires are customized to the needs of the particular sponsor/study. The Investigator information is then loaded into the product’s relational database and users are defined to the system. Customized reporting is available.

eClinDirect CTMS benefits:

Real-Time, Online Access to Information

Once entered into eClinDirect, CRA monitoring visit reports are available online, in real-time for all stakeholders with access. Role-based security provides various levels of access control.

Flexible CTMS, Easy Configuration

eClinDirect CTMS is easily configurable. The configuration process begins with a determination of desired access control levels and the electronic workflow of the monitoring visit reports. Next, online monitoring visit report forms are customized to the needs of the particular sponsor or study.

Online Visit Monitoring Forms Workflow

eClinDirect validates that CRAs completed the monitoring form questionnaires, and supplied comments for questions with negative answers. Online forms are routed via electronic workflow, using an e-signature design. E-mail notifications are available and all actions write to an Audit Trail.

Protocol Deviations

Extensive information about protocol deviations is recorded from within the visit monitoring form. Additionally, violation classifications are configurable.

Document Management

Paper documents collected at the sites are identified and electronic documents,if available, are uploaded into a repository. The extensive meta-data stored with the document is used as filter criteria when running the various document reports. Document categories and types are configurable, and the collection status of essential regulatory documents is tracked.

Investigator Contact Information

eClinDirect stores investigator and other stakeholder contact information, status, and credentials. Updated contact information is immediately available online. Additionally, Investigator site information pre-populates in forms, reducing data entry.

Payments

Various payment categories and payees are configured and budget milestones defined. Payments are recorded against these budget milestones. A variety of budget vs. actual reports are available.

Reporting Functions

eClinDirect’s real-time standard and customized reports provide easy access to metrics, workflow events, action items, documents collected, protocol deviations, and adverse events, summarizing the details needed to ensure the steady progress of any clinical trial.

DSG Drug Safety system

DSG’s eCaseLink Drug Safety system streamlines the safety recording, reporting process, data entry on Serious Adverse Events (SAEs), and can store documents associated with the safety event that facilitate the generation and tracking of queries.

The DSG Drug Safety system enables medical monitors to electronically record the SAE form information received from a site. Fields read from DSG’s eCaseLink EDC system and pre-fill the online form, such as demographic information. Key events, dates and status are easily tracked. The system alerts the medical monitor to differences between the safety data entry form and data entered into eCRFs within the eCaseLink EDC system.

Data Capture of a Safety Event

An online data entry form facilitates the capture of extensive information about the safety event. User can generate an FDA 3500A MedWatch or CIOMS form containing the entered data.

Extensive Tracking

In addition, the DSG Drug Safety system can record extensive tracking information about the safety event, including the date and status of submissions to regulatory agencies. The DSG Drug Safety system makes it easy to upload documents associated to the adverse event, making it convenient to access critical documentation at any time. The system can also facilitate the generation and tracking of queries associated with the safety event. The configurable workflow allows multi-level approval and collaboration within different departments and sites.

eCaseLink IWRS (Interactive Web Response System)

DSG’s award winning IWRS is a seamlessly integrated component of eCaseLink that helps you to easily manage randomization, subject enrollment and drug supply management in any clinical trial.

Randomizing, enrolling study subjects and managing drug supply, is crucial to the success of clinical trials, regardless of phase. In today’s Internet-savvy world, Interactive Web Response Services (IWRS) are quickly replacing outmoded and time consuming voice response systems.

eCaseLink’s IWRS automated randomization systems use the latest statistical methods, programming and validation procedures. This ensures quick, accurate patient assignments, balanced and valid subject assignments. The IWRS functionality completely manages the supply chain from shipment to re-supply thus ensuring proper kit numbers and the monitoring of defective or damaged supplies.

eCaseLink’s IWRS increases efficiency and productivity with lower error rates, and eliminates the need for costly and inefficient IVR systems. eCaseLink’s IWRS delivers savings of over $100,000 per study, on average.

The benefits of eCaseLink’s IWRS:

Stand-alone or full EDC Integration

IWRS from DSG is seamlessly integrated with eCaseLink™ EDC software, reducing the need or completely eliminating traditional telephone-based Interactive Voice Response Systems (IVRS). IWRS from DSG provides advanced, award-winning technology, enabling users to fully leverage eCaseLink.

Award Winning Technology

DSG is the industry leader in integrated EDC technology. The Society for Clinical Data Management recognized DSG with its Data Driven Innovation Award in 2007 for DSG’s work with Sirion Therapeutics developing state-of-the-art patient randomization, drug delivery and supply management, and reconciliation in real-time within eCaseLink in six studies.

Lower Costs and Increased Efficiency

DSG’s Interactive Web Response System (IWRS) and integrated EDC functionality enables continuous reconciliation to occur, minimizing the need for additional external reconciliation. This enables sites to completely replace IVRS with the less costly and more efficient Web-based option. DSG delivers savings on average of over $100,000 per study through the use of its IWRS.

With many sites and sponsors opting for Web-based solutions, companies can deploy IWRS without the need for external feeds. Immediate randomization and drug supply management can be done on-site with better tracking and no need for “on-call” representatives across geographies and time zones. Sites can also eliminate waste, (especially with expensive therapies) and management has the ability to generate reportage on drug kit usage, randomization and inventory supply all in one location.

Automated Patient Randomization

eCaseLink’s IWRS automated randomization systems use the latest statistical methods, programming and validation procedures. This ensures quick and accurate patient assignments, and balanced and valid subject assignments. These services range from block assignments to complex dynamic and adaptive randomization.

Inventory Management DSG’s IWRS provides a centralized pathway to complete clinical trial drug supply. For Sponsors using Just In Time (JIT) methods of controlling inventory, a Web-based solution has adequate supply sent to sites from depots throughout the supply chain. This key function reduces human error that’s common to traditional IVRS and paper-based methods. eCaseLink IWRS completely manages supply chain from shipment to re-supply to ensuring proper kit numbers and monitoring defective supply. eCaseLink generates automated messages triggered by a pre-set low supply threshold.