The patient advocacy firm Inspire has released the results of its second annual Insights From Engaged Patients survey. Over the last two years, Inspire has captured insights from nearly 24,000 patients and caregivers who face multiple health conditions. The survey looked into several areas related to patient interactions with social media, physicians, and most importantly, pharma companies.
Radio Free Asia (RFA) is reporting that a government investigation in China has revealed fraudulent practice on a massive scale in clinical trials. China's food and drug regulator recently carried out a one-year review of clinical trials, concluding that more than 80 percent of clinical data is "fabricated," state media reported.
When Pfizer partnered with IBM to try and transform how clinical trials for Parkinson’s patients are conducted, the company had a vision that was both revolutionary and futuristic. The plan was to take a group of patients, place them in a specially designed home to live for a period of time, and use sensor technology to monitor their capabilities.
Data managers are critical to the clinical research process. It’s the data they collect which will ultimately determine whether a new drug gains FDA approval. Recognizing that, the Society for Clinical Data Management (SCDM) was established to work with the teams creating clinical trials, writing the protocols, and identifying the information that needs to be captured. Over the years, the information gathered by SCDM members has been incorporated into a guide book of Good Clinical Data Management Practices, which SCDM is now making available to nonmembers as well as association members.
In 2007 Synergy opened a Clinical Data Management Department with local, low-budget projects and decided to implement an open source EDC solution as a clinical data collection tool. This tool required installation and validation every time a new project was started. When the number of projects started to multiply, management quickly realized they had two options: expand their IT resources to support data management applications or outsource. They chose the second option so they had to find a cost-effective, pay-as-you-go, cloudbased EDC solution which would allow them to move their current EDC projects without interruption.
In 2005, Abbott sanctioned an executive-sponsored governance body to drive the development and implementation of enterprise-wide study build, data capture and trial management processes using a single electronic data capture (EDC) vendor for all clinical studies. The objective was to quickly move the lion’s share of studies to electronic capture means while maximizing site acceptance.
Today, EDC systems are widely adopted by life science companies and well established as a critical technology for conducting clinical research, especially for large multi-site trials.
Mobile health (mHealth) technology will redefine how we conduct clinical R&D. Consumer-friendly technologies, including remote sensors, wearable devices and mobile apps, offer clinical development access to potentially rich, sensitive patient data that not only complements existing sources—providing a more complete view of therapy safety and efficacy—but may also provide a better understanding of disease.
Why in this day and age, with people connected 24x7 via smartphones and apps, do clinical trials still use paper to capture patient-reported outcomes (PROs)? ePRO solutions have been around for decades, but up to half of studies still use paper to capture patient assessments.
As clinical trials represent a substantial portion of R&D costs, the adoption of electronic data capture (EDC) over the last 15 years has contributed to these efficiencies. However, forward-thinking life sciences companies increasingly recognize that replacing paper with EDC is not an end in itself.
Medidata (NASDAQ: MDSO), the leading global provider of cloud-based solutions for clinical research in life sciences, today announced the completion of a method development project conducted in partnership with GlaxoSmithKline plc (GSK) to evaluate the impact of unifying mobile health (mHealth) devices with cloud-based technologies in a clinical trial setting. The joint initiative assessed the capabilities of mHealth tools and evaluated how they could be used to enable a new model for clinical trial conduct that aligns site and patient needs with faster study execution and reduced costs.
Medidata (NASDAQ: MDSO), a leading global provider of cloud-based solutions for clinical research in life sciences, and Pharmaceutical Product Development, LLC (PPD), a global contract research organization (CRO), today announced they are expanding their partnership to provide the life science industry with a more comprehensive approach to risk-based
monitoring (RBM)—aimed at conducting drug development more intelligently, more quickly and more cost-effectively.
Comprehend today announced it has secured $21 million in Series B financing to accelerate clinical development through its cloud-based business intelligence solutions, enabling life science companies to bring new treatments and devices to market faster and more affordably. The round was led by Lightspeed Venture Partners with support from existing investor Sequoia Capital. Lightspeed partner Peter Nieh joined the company’s board of directors.
Medidata (NASDAQ: MDSO), the leading global provider of cloud-based solutions for clinical research in life sciences, today announced that it is partnering with TransCelerate BioPharma Inc. ("TransCelerate") on a project designed to inform the nonprofit organization’s continued efforts to modernize and streamline the way clinical trials are conducted and monitored worldwide.
Exco InTouch, the leading provider of patient engagement and data capture solutions for clinical research and healthcare providers, recently announced the appointment of Laurence Burke as Vice President of Operations.
NextDocs, a leading provider of regulated content management and compliance solutions, announced recently that the company has received a $13.5M round of investments and funding commitments. The funding round was led by OpenView Venture Partners with participation by Eastward Capital and Bridgebank Capital
PharmaMar, a Spanish biopharmaceutical company, has selected Medidata Solutions (NASDAQ: MDSO) for its industry-leading electronic data capture (EDC) and clinical data management (CDM), safety data capture and reporting, and medical coding solutions. A member of the Zeltia Group and a leader in the development of antitumor drugs of marine origin, PharmaMar said the company’s investment in the Medidata Clinical Cloud™ will efficiently streamline its clinical trial processes in its mission to deliver drugs that treat cancer and rare ("orphan") diseases.
Merge Healthcare Incorporated, a leading provider of clinical systems and innovations that seek to transform healthcare, recently announced that NorthWise Services (NWS) has partnered with Merge and selected eClinical OS™ to collect, manage and report on clinical trials data across all studies.
Exco InTouch, the leading provider of patient engagement, data collection and communication solutions for the pharmaceutical and healthcare sectors, recently announced that it has joined the Electronic Patient-Reported Outcome (ePRO) Consortium, a programme run by the Critical Path Institute (C-Path), which strives to enhance the quality of patient reported outcomes (PRO) in the evaluation of new pharmaceuticals.
Stiris Research has entered into a strategic partnership with Statistics & Data Corporation (SDC) to offer seamless implementation of full-service Clinical + Biostatistics and Data Management/EDC solutions.
Clinovo will release for the first time at the annual Outsourcing in Clinical Trial West Coast conference (booth #43), the new version of ClinCapture, its open-source Electronic Data Capture (EDC) system.
Merge Healthcare Incorporated, a leading provider of clinical systems and innovations that seek to transform healthcare, recently announced that NCGS Incorporated has selected Merge’s eClinical OS™ and clinical trial management (CTMS) solution to streamline data management activity through electronic data capture (EDC) technology transfer and improve study management efficiency.
Merge Healthcare Incorporated, a leading provider of clinical systems and innovations that seek to transform healthcare, recently announced that Datapharm Australia Pty Ltd. has selected Merge’s eClinical OS™ solution to bring EDC in-house and provide control of electronic case report form (eCRF) creation and mid-study adjustments.
DATATRAK International, Inc. (OTCQX: DATA), a technology and services company focused on global eClinical solutions for the clinical trials industry, today announced the award of a multi-million dollar, five-year technology and services agreement with Bellicum Pharmaceuticals.