Sofpromed CRO Selects OmniComm’s TrialMaster® as EDC for Cancer Trials

Patricio Ledesma

Head Of Clinical Operations at Sofpromed

23 December, 2019

Oncology-focused CRO will use TrialMaster EDC to support clinical data management services for sponsors in the oncology sector, particularly in phase I-IV cancer trials

FORT LAUDERDALE, FL, December 16, 2019 – Sofpromed, a European full service contract research organization (CRO) specializing in the integral management of phase I-IV clinical trials in oncology, has selected TrialMaster as their preferred electronic data capture (EDC) system to support their clinical data management services.

TrialMaster is one of the primary eClinical software solution offerings from OmniComm Systems, Inc., an Anju Software company and a leading global provider of clinical data management technology. In addition to data management services, Sofpromed specializes in providing oncology-focused clinical trial services for studies in solid tumors and hematologic malignancies for the pharmaceutical and biotechnology industries.

“As an oncology-focused CRO, we are pleased to provide Omnicomm’s TrialMaster EDC solution to our customers, particularly to pharma and biotech companies conducting phase I-IV clinical studies for the development of cancer drugs in the United States and Europe,” said Patricio Ledesma, Sofpromed’s chief executive officer (CEO).

He continued, “[The] TrialMaster EDC Suite will greatly enrich and strengthen our data management and statistical programming services for clinical trials. Sponsors will benefit from solid, high quality clinical data, while investigators and study coordinators will certainly value TrialMaster’s intuitive design and ease of use.”

As a full service provider of clinical trial management services across Europe, Sofpromed aims to help customers accelerate study start-up, recruitment, and data analysis by offering oncological and regulatory expertise, as well as technical proficiency. Sofpromed considers the data management and reporting features of TrialMaster to be of particular value to support their operations.

CEO Ledesma stated, “With TrialMaster’s ad hoc report tool our data managers will be able to generate dynamic reports, such as patient profiles, recruitment, and form status. In addition, the system’s built-in data mapping and export tools will further improve our capabilities to quickly produce robust SDTM datasets for FDA submissions, which is an absolutely critical need for the pharmaceutical industry.”   

“We are delighted to partner with Sofpromed to conduct their oncology trials,” said Rohit Mistry, OmniComm’s senior vice president of business development for the EMEA region. “The studies they conduct are complex in nature, requiring an EDC that provides flexibility, yet still very intuitive for sites globally to use.

With the support of our European delivery team, Sofpromed is now enabled to incorporate TrialMaster study build services into their core services, offering sponsors their oncological expertise coupled with the most innovative EDC solution on the market.”           

About Sofpromed

Sofpromed is a full service contract research organization (CRO) specialized in the management of phase I-IV clinical trials in oncology. The company provides clinical data management, biostatistics/statistical programming, regulatory, monitoring, and pharmacovigilance services for the pharmaceutical and biotechnology industries, with particular expertise in cancer studies.

Sofpromed offers Omnicomm’s TrialMaster® EDC Suite to clinical trial sponsors worldwide, including comprehensive data management and SAS programming services in compliance with CDISC (CDASH, SDTM, and ADaM) standards for FDA submissions. For more information about Sofpromed, visit: www.sofpromed.com.

About OmniComm Systems, Inc.

OmniComm Systems, an Anju Software Company, is a healthcare technology company that provides web-based electronic data capture and eClinical solutions and related value-added services to pharmaceutical and biotech companies, contract research organizations and other clinical trial sponsors principally located in the United States, Europe and East Asia.

OmniComm’s proprietary EDC and eClinical software applications – TrialMaster®, TrialOne®, eClinical Suite, Promasys®, IRTMaster, AutoEncoder and Acuity – allow clinical trial sponsors and investigative sites to securely collect, validate, transmit and analyze clinical trial data. OmniComm is headquartered in Fort Lauderdale, FL. 

Anju Software, Inc. is a leading provider of comprehensive software solutions to the life sciences industry that provides an integrated platform spanning clinical operations, medical affairs and commercial divisions, including integrated data intelligence. Anju is a privately owned, Abry Partners portfolio company. For more information about OmniComm, visit: www.omnicomm.com.

 

Patricio Ledesma

Patricio Ledesma (B.Eng Concordia University, Montreal, Canada and Master’s Degree in Clinical Trials, University of Seville, Spain) is the Head of Clinical Operations and Founder at Sofpromed CRO. Patricio is a professional consultant providing comprehensive, one-stop expert advice and guidance to biotechnology and pharmaceutical companies worldwide in the field of clinical trials and drug development. He is personally and enthusiastically devoted to helping biotech Chief Executive, Operations, Scientific, Medical, and Regulatory Officers in the planning and execution of phase I-IV clinical trials across North America, Europe, Asia-Pacific, Latin America, and Middle East regions. You can contact Patricio at: +34 607 939 266  pledesma@sofpromed.com 

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Patricio Ledesma

Patricio Ledesma (B.Eng Concordia University, Montreal, Canada and Master’s Degree in Clinical Trials, University of Seville, Spain) is the Head of Clinical Operations and Founder at Sofpromed CRO. Patricio is a professional consultant providing comprehensive, one-stop expert advice and guidance to biotechnology and pharmaceutical companies worldwide in the field of clinical trials and drug development. He is personally and enthusiastically devoted to helping biotech Chief Executive, Operations, Scientific, Medical, and Regulatory Officers in the planning and execution of phase I-IV clinical trials across North America, Europe, Asia-Pacific, Latin America, and Middle East regions. You can contact Patricio at: +34 607 939 266 pledesma@sofpromed.com