DSG Press Releases

FDA approves Nanocoated CoronaryStent System using DSG’s eClinical Systems.

MALVERN, Pa., March 23, 2017, CeloNova Biosciences, Inc. leveraging products and services provided by DSG Inc., a leading eClinical software technology and data management global services firm, has recently received US Food and Drug Administration (FDA) approval of its first-in-class COBRA PzF ™ NanoCoated Coronary Stent System.

DSG’s eCaseLink EDC allowed CeloNova Biosciences to manage subject enrollment and capture data efficiently in the global clinical trial of the COBRA PzF Coronary Stent. DSG handled all aspects of clinical study data management from database setup through lock.DSG's data management team added value to their eCaseLink EDC solution by providing CeloNova Biosciences with clean, timely, and cost-effective deliverables and week-to-week metrics showing their own progress throughout the lifespan of the study,” said Mark Barakat, MD, Senior Director, Medical Affairs at CeloNova.

DSG, INC. ACCELERATES GROWTH WITH OPENING OF NEW OFFICE IN BANGALORE, INDIA

MALVERN, Pa., Bangalore, India, January 2017 — DSG, Inc., leading provider of eClinical technology solutions, data management, professional services and customer support recently opened a new office in Bangalore, India, to accommodate rapid growth and better serve client needs. DSG's Bangalore office will complement its existing facility located in Noida, India. DSG Bangalore’s state-of-the-art facility will occupy a floor in the Prestige Shantiniketan building. The new office space will accommodate over 300 people and support the company’s growth strategy.

ORBUS THERAPEUTICS, INC. SELECTS DSG, INC. FOR EDC & IWRS IN RECURRENT ANAPLASTIC ASTROCYTOMA CLINICAL STUDY

MALVERN, Pa., September 30, 2016 — Orbus Therapeutics, Inc., a private, clinical-stage biopharmaceutical company focused on the development and commercialization of therapies that treat rare diseases, has selected DSG, a leader in electronic data capture (EDC).

SUPERNUS PHARMACEUTIACALS SELECTS DSG FOR EDC AND IWRS PHASE 3 CLINICAL STUDIES

MALVERN, Pa., April 01, 2016, — DSG a leader in electronic data capture (EDC), was selected by Supernus Pharmaceuticals, a specialty pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system diseases, to provide a fully supported eCaseLink EDC system, including IWRS Web-based Randomization-Clinical Supply, a Central lab and third-party CRO data integration, and data management services for two blinded Phase 3 clinical studies on impulsive aggression in pediatric patients being treated for Attention Deficit/Hyperactivity Disorder (ADHD).

DSG, INC. PARTNERS WITH BEDROCAN CANADA AND TWEED IN A NON-INTERVENTIONAL UNBLINDED STUDY TO EVALUATE QUALITY OF LIFE IN PATIENTS TREATED WITH MEDICAL MARIJUANA

MALVERN, Pa., February 16, 2016,— DSG a leader in electronic data capture (EDC), has teamed up with Canada’s leading licensed producers of medical grade marijuana, Bedrocan Canada Inc. and Tweed Inc., subsidiaries of Tweed Marijuana Inc., to provide EDC and Electronic Patient Reported Outcomes (ePRO) services for the companies’ current large-scale in-country clinical study, the largest of its kind. The primary objective of the study, which is intended to continue for three years, include more than 50 sites, and enroll up to 6,000 patients, is to evaluate the quality of life (QoL) of patients before and after treatment with medical cannabis.

INTEGRIUM ENTERS INTO A MULTI-YEAR ENTERPRISE AGREEMENT WITH DSG, INC.

MALVERN, Pa., May 28, 2015, — DSG a leader in electronic data capture (EDC), today announced Integrium has signed an Enterprise Licensing Agreement for DSG’s eCaseLink solutions and services.“After years of using DSG’s highly regarded EDC platform, we’re delighted at the opportunity of being able to offer DSG’s eCaseLink EDC directly to our clients along with the integrated CTMS, Site Payment, Protocol Deviation and Safety System Modules that unify and simplify the logistics of electronic trial management within a single enterprise system. We believe that these unified modules and accompanying cutting-edge features like Risk-Based monitoring not only increase our efficiency, but enable us to provide more comprehensive, cost-effective and selective solutions to our clients,” said David Smith, MD.

SPECTRUM PHARMACEUTICALS SELECTS DSG FOR BLENDED SAAS AND TECH TRANSFER EDC

MALVERN, April 28, 2015, – Spectrum Pharmaceuticals for its Phase 3 pivotal oncology studies over the past three years, has engaged DSG for full service EDC, IWRS and data management services, including a rescue study. Recently, Spectrum personnel trained on DSG’s Designer tool to begin building earlier phase studies independently of DSG.

DSG, INC PARTNERS WITH SOLIGENIX TO BATTLE CUTANEOUS T-CELL LYMPHOMA

MALVERN, Pa., April 7, 2015 – DSG, a leader in electronic data capture (EDC), has teamed up with Soligenix to provide EDC, IWRS Web-based patient randomization and data management services for their current Phase 3 clinical study of SGX301 (synthetic hypericin) coupled with visible light activation in the treatment of Cutaneous T-Cell Lymphoma.

DRUG APPROVED IN PIVOTAL STUDIES USING DSG’S FULLY ELECTRONIC SOURCE DATA

MALVERN, Pa.,March 3, 2015 – DSG, Inc and Sirion Therapeutics collaborated in launching the industry’s first two pivotal Phase 3 studies using entirely electronic source data collection for the safety and efficacy of Difluprednate in the management of inflammation following ocular surgery.

DSG DEVELOPS ACCELERATED PROJECT TEAM

MALVERN, Pa., January 29, 2015 DSG has announced today the formation of an internal team and process known as FAST to develop and launch high functioning EDC systems for Sponsors who need extraordinarily rapid eClinical system implementations.

DSG & OPKO HEALTH ENTER INTO ENTERPRISE LICENSING AGREEMENT FOR FULLY INTEGRATED EDC, IWRS, SAFETY, AND TRIAL MANAGEMENT SOLUTION

MALVERN, Pa., November 4, 2014 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.

DSG, INC TO ATTEND SCDM 2014 CONFERENCE

Joining our team in Las Vegas is Suzanne Lamerand, Vice President of Data Management for DSG. Ms. Lamerand is celebrating her 20th year in Data Management and is a noted expert in CDM. She joined the DSG team in 2007 and prior spent nearly 10 years at McNeil Consumer Healthcare, in various data management roles, concluding her tenure as Associate Director of Data Management. Ms. Lamerand helped McNeil become an early adopter of electronic data capture (EDC) and electronic patient reported outcomes.

REGENESIS AND DSG COLLABORATE ON EDC WITH IWRS AND WEB-BASED ELECTRONIC PATIENT REPORTED OUTCOMES

MALVERN, Pa., September 9, 2014 Regenesis Biomedical, a medical technology company focused on energy-based therapeutics for pain management, has selected DSG’s eCaseLink as its provider for electronic data capture (EDC), web-based randomization, as well as eCaseLink.Me, DSG’s ePRO solution, for a new study of their previously approved PROVANT therapy in the treatment of post-operative pain.

DSG’s eCaseLink.Me is a highly affordable, proven, agency acceptable, fully-configurable electronic patient reported outcomes solution that is entirely web-based. It works on any browser or web-enabled device, so that patients may enter data conveniently from any wifi-enabled location. Regenesis Biomedical is experiencing the full benefit of specific eCaseLink.Me features such as auto emails, time controlled login, patient-configurable user-interface, and dynamic release of questionnaire all with zero training.

"This has been a great collaborative effort,” says Richard A Isenberg, MD, VP of Clinical and Regulatory Affairs for Regenesis Biomedical, Inc.

ROMARK LABORATORIES SELECTS DSG FOR INFLUENZA STUDY

Malvern, Pa., March 12, 2014 As influenza continues to lead to more than 226,000 hospitalizations and 24,000 deaths annually in the United States alone, new treatments are critical for fighting the latest strains of the virus. To combat this seasonal issue, Romark Laboratories will complete the advanced development of Nitazoxanide (NT-300) as a treatment for acute uncomplicated influenza in a Phase III clinical study using the integrated eClinical products and services from DSG.

We looked at a variety of solutions, but the fact that DSG offered Romark an integrated, one-stop shop for our needs, all of which are extremely user-friendly and intuitive for site users made the difference, said Marc Ayers, CEO of Romark Laboratories. DSG’s experience and flexibility to meet our requirements ensures our study can run quickly, accurately and within our budget.

ARIOSA DIAGNOSTICS thanks DSG for great customer service.

Malvern, Pa., FEB 28, 2014 Ariosa Diagnostics would like to publically thank DSG for the great customer service you have provided in support of this project. It isn’t over yet but I wanted to put this out there now. Thanks for everything you have done so far. You have gone over and above to help get as much as we can out of the system with weekend and evening support and you always have a positive can do attitude. Thanks for that!

Sincerely,
Director of Clinical Development

AUXILIUM PHARMACEUTICALS SELECTS DSG AS EDC PROVIDER

— DSG’s Electronic Data Capture, IWRS and data management services used for XIAFLEX® program to support sBLA for Peyronie’s Disease.

Malvern, Pa., Oct. 08, 2012 Auxilium Pharmaceuticals, a leading company focused on products for urology and sexual health, has selected DSG’s eCaseLink™ as its provider for electronic data capture (EDC). Auxilium will also use DSG’s interactive web response system (IWRS) and clinical data management services for supporting the submission of a supplemental Biologics License Application (sBLA) to the FDA for their XIAFLEX® program in Peyronie’s Disease by end of 2012.

DSG TO EXHIBIT AT THE SCDM 2012 ANNUAL CONFERENCE

— Media invited to meet DSG's head of clinical data management at the SCDM 2012 Conference, Los Angeles.

Malvern, Pa., Sept 20, 2012 DSG, Inc., a leader in clinical data management and electronic data capture for clinical trails invites the media to meet with Suzanne Lamerand, vice president of data management for DSG at the upcoming annual meeting of the Society for Clinical Data Management. Ms. Lamerand is a noted expert in CDM and has presented at this conference in past years.

LATEST INNOVATIONS FROM DSG UNVEILED THIS WEEK AT SCDM 2012

— Collaborative effort creates Protocol Violations module for eCaseLink™ Electronic Data Capture —

Malvern, Pa., Sept 18, 2012 The management of Protocol Violations (PVs) is a consistent area of difficulty for Clinical Data Management (CDM). Often this is due the fact that multiple parties from site investigators, clinical research associates, data managers and others are involved in the process, leading to potential data integrity issues and forcing companies to rely on a cumbersome paper-based approach. Teaming up with customer Human Genome Sciences (HGS), DSG will unveil its new module for PVs at the 2012 Society for Clinical Data Management (SCDM) Annual Conference in Los Angeles Sept. 22-25.

ARIOSA DIAGNOSTICS SELECTS DSG AS EDC PROVIDER

— DSG’s electronic data capture used by Ariosa Diagnostics in study on safe, new methods for prenatal testing.

Malvern, Pa., April 23, 2012 Ariosa Diagnostics, a molecular diagnostics company focused on prenatal testing, has chosen to use DSG’s eCaseLink EDC (electronic data capture) system for the NEXT (Non-Invasive Chromosomal Examination of Trisomy) study.

DSG TO EXHIBIT AT THE 15th ANNUAL DIA WORKSHOP IN JAPAN

— Attendees to learn how they can reduce costs and increase clinical trial success.

Malvern, Pa., January 16, 2012 DSG, Inc., an industry leader in clinical trial data collection and management, will be exhibiting at the 15th Annual DIA Workshop in Japan for Clinical Data Management at the Tower Hall Funabori in Tokyo, January 26th and 27th. DSG will be demonstrating their eCaseLink EDC software, and its complete line of integrated solutions designed to reduce costs and increase clinical trial success rates.

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