Category: eClinical Solutions

09 May 2018
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How Blockchain may impact Clinical Trials

With blockchain being the world’s leading software platform for digital assets, the application of the technology in clinical trials has sparked discussion at PanAgora’s AI & Machine Learning in Clinical Trials Summit last month.

In a recent article published on Applied Clinical Trials , Moe Alsumidaie held an interview with Munther Baara (Head of New Clinical Paradigms at Pfizer) about his perspectives on how blockchain may impact clinical trials.

After describing blockchain technology, Munther Baara shared his insight on the use of blockchain in clinical trials:

“If clinical trials can employ blockchain technology, the aggregated data would be immediately available when a patient enrolls in a study, which can save time during screening. Research sites and sponsors would have the ability to view original and quality source documentation in real-time, which minimizes medical history data errors. Another benefit of using blockchain would be the ability for patients to better connect with individuals who have similar conditions (e.g., in rare disease populations), which can enhance trial referral potential. The drug supply chain could also be a great area where the industry can track investigational products all the way from inception to consumption, connect to the patients to gather medication adherence data, and facilitate drug accountability documentation. Sponsors can also use blockchain to register clinical trials and share study results with other researchers. Blockchain has the potential to be a game changer, as it would change the way we conduct business, not only in pharma but also globally across other industries.”

 

To read the full article visit http://www.appliedclinicaltrialsonline.com/blockchain-concepts-emerge-clinical-trials

 

 

02 May 2017
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TCD joins EOH as the group grows with strategic changes taking effect in May 2017

We are delighted to share the following significant changes and positive developments which took place recently within the TCD Group.

New Ownership

EOH, a JSE-listed South African based Knowledge Management group, have been in negotiation with the TCD Group since the last quarter of 2015, sharing the strategic objective to expand in the field of healthcare. EOH consists of a diverse portfolio of specialised industries in 21 countries across four continents.

The groups came to agreement in October 2016 and the transaction was completed in February 2017. EOH Holdings is now the 100% shareholder of the TCD Group of companies. We are excited by this positive development which opens many new horizons through the global profile of our new proudly South African owners.

The EOH philosophy involves sustaining successful acquisitions by building upon the inherent culture. The TCD Group will remain easily recognisable, building on our rich legacy, striving as always for continuous improvement.

Expansion of the TCD Group

The rapid evolution of the TCD Group expanded the original Triclinium into a full-service CRO (Contract Research Organisation), with a growing range of services and geographical footprint. Triclinium’s sister companies, within the TCD Group now consists of:

  • TCD Outcomes Research: The TCD Group developed a Health Economics and Outcomes Research (HEOR) organisation, through an acquisition of HeXor (a late phase development and pharmacoeconomics company), combined with the Late Phase Clinical Development expertise of TCD.
  • TCD e-Clinical Solutions: The TCD Group created an e-Clinical Solutions division which includes Software as a Service solution. TCD e-Clinical Solutions is focused around improving the outcome of clinical trials from a quality and efficiency perspective. Services include Electronic Data Capture (EDC), Electronic Medical Records (EMR), Electronic Patient Reported Outcomes (ePRO), Electronic Clinical Outcome Assessments (eCOA) and Mobile Health (mHealth), etc.
  • TCD Global Data Services: The TCD Group established and consolidated its Data Management and Biostatistics division under the TCD GDS brand, which is spearheaded out of South Africa and Bangalore, India.
  • TCD-MENA: The TCD Group established a full-service CRO based in Cairo, Egypt through a Joint Venture to focus on the Middle East and North Africa region.
  • PharmaLTX: The TCD Group established a software development company which specialises in software solutions in the wider health care sector such as partnering with Ministries of Health, Regulatory agencies, Institutional Review Boards, Universities, Clinical Research Centres, etc.

 

New TCD Group Chairman

The mandate to meld the member companies into a synergistic group has been entrusted to Dr Tienie Stander, founder of HeXor Pty Ltd., current Managing Director of TCD Outcomes Research, and now also the inaugural Chairman of the TCD Group.

Change in Managing Director of Triclinium Clinical Development

To those who know the company well, the most visible change is that after 17 years at the helm, founder Victor Strugo will relinquish the position of Managing Director to Abraham van Wyk, effective 1st May, 2017. Abraham has been increasingly involved in TCD executive functions since 2014 and his promotion is fully endorsed by TCD’s Board of Directors.

Victor will nevertheless remain active and visible in the new role of TCD Group Strategic Adviser, facilitating a smooth management transition, supporting key projects and developing new horizons for the company that he created in February 2000.

Our electronic media will be updated accordingly over time. We look forward to maintaining and strengthening our association with your organisation through this transition and to offer an ever-improving and broadening range of services in the years ahead.

For queries or more information, contact us at corporate.communications@tcd-global.com

28 Dec 2016
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Exciting technology trends for clinical trials in 2017

“A lot has happened in the clinical trials industry in 2016, as biopharmaceutical enterprises are just starting to delve into clinical trial innovation. Risk Based Monitoring (RBM) is starting to expand into new concepts in Quality Risk Management; enterprises have aggregated their data to generate clinical trial predictive models; the definition of patient centricity is cementing; incorporating endpoint adjudication methodologies in trial design is talked about often; subject enrollment is increasing in efficiency and scalability through big data, and mHealth pilots are starting to demonstrate promising data.” – Moe Alsumidaie, Author at Applied Clinical Trials.

Read the full article at http://www.appliedclinicaltrialsonline.com/clinical-trial-innovation-what-s-come-2017

[source : Moe Alsumidaie – http://www.appliedclinicaltrialsonline.com/clinical-trial-innovation-what-s-come-2017]

18 Nov 2016
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How 3-D printing can save lives in the medical field

For most people the concept of three-dimensional (3D) printing is still seen as something from a science fiction novel, but the medical world is busy embracing this technology and is a major driving force behind its growth.

Dr Thomas Bartel, section head of the Heart and Vascular Institute at Cleveland Clinic Abu Dhabi said the following : “In health care, 3-D printing’s most impressive function is its ability to replicate organs to help plan for or simulate surgeries. 3-D printing helps us personalise care while minimising risk.”

The costs related to 3-D printing have dropped considerably over the past 2 years and, according to consultants Frost & Sullivan, the 3-D printing industry alone will become a $6 billion market by 2025.

For the full article please visit : http://www.thenational.ae/arts-life/well-being/how-three-dimensional-printing-can-save-lives-in-the-medical-field

[image source : http://www.starinfranet.com/]

25 Oct 2016
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Health tech startup Cardiogram screens users’ cardio health using wearable device

“In the last six months, we’ve gathered more than 10 billion sensor measurements from more than 100,000 contributors. Of course, raw sensor data is not a biomarker, a biomarker is not a diagnosis, and a diagnosis is not a therapeutic,” co-founder of Cardiogram Brandon Ballinger wrote in a blog post.

“This volume of data has let us achieve a c-statistic (an accuracy measure) of above 90% in detecting atrial fibrillation, the most common abnormal heart rhythm,” Ballinger said. “We think it’s important for even young digital health companies to submit their work to peer review, so you’ll see us submit to both medical journals and artificial intelligence conferences in coming years as well.”

For the full article please visit : https://techcrunch.com/2016/10/20/cardiogram-raises-2-million-to-predict-heart-health-issues-using-wearbles/

[image source : https://cardiogr.am/]

11 Oct 2016
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How mHealth Technology Supports Patient Engagement Strategies

mHealth (mobile Health) is more and more becoming the standard when it comes to Patient Reported Outcomes (ePRO) or patient engagement in the discipline of pharmacovigilance. According to the Center for Connected Health Policy, remote patient monitoring is the use of “digital technologies to collect medical and other forms of health data from individuals in one location and electronically transmit that information securely to health care providers in a different location for assessment and recommendations.”

Capital Blue Cross conducted a study in 2016 and their research found that when heart failure patients used remote patient monitoring devices, it cut hospitalizations by nearly one-third. “Not only is chronic disease expensive, difficult to manage and a drain on our healthcare system, but it also takes a toll on patients and families, decreasing their quality of life and often leading to an accelerated transition out of the home and into facility-based care,” said Jennifer Chambers, MD, Chief Medical Officer at Capital Blue Cross.

For the full article please visit : http://patientengagementhit.com/features/how-mhealth-technology-supports-patient-engagement-strategies

26 Sep 2016
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Microsoft helping to find cancer treatments

The Microsoft corporation is assisting the oncology team at the Australian National University (ANU) to uncover more about the genomics of cancer. This process will help identify which genes have been affected in a negative way in the genome. “The collaboration between biologists and computer scientists is actually key to making this work,” Microsoft’s corporate vice-president Jeannette Wing said.

Cheng Soon Ong , an adjunct associate professor at ANU and principal research scientist at CSIRO, said a clearer understanding on genomics would allow for more targeted treatment. “Once you have been diagnosed with cancer your genomics can give indications to the doctor [as to] which treatment you’re more likely to respond to,” Professor Soon Ong said.

For the full article please visit : http://www.abc.net.au/news/2016-09-21/microsoft-to-use-computer-science-to-help-find-cancer-treatments/7865748

30 Aug 2016
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Digital Healthcare Market Growth

The growth of the digital healthcare market has been steady over the past 10 years but in recent times this growth curve has changed exponentially. The introduction and adoption of mobile applications and wearable devices related to wellness and healthcare have been one of the main drivers behind this.

“Mobile network operators view mHealth as a lucrative opportunity for the monetization of their mobile connectivity services as a growing proportion of their subscribers adopt healthcare-centric wearables.  Given that most operators have established themselves as reputable consumer brands, they are also eyeing on opportunities to offer services beyond simple connectivity. Many operators already offer branded or co-branded end-to-end mHealth solutions to their customer bases.” according to research done by the team at ReportsnReport. [http://www.reportsnreports.com/]. Driven by the thriving ecosystem, research estimates that the mHealth market will account for nearly $18 Billion in 2016 alone.

For the full story regarding trends in the digital healthcare space please visit : http://news.sys-con.com/node/3902137

09 Aug 2016
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CDISC and TransCelerate Announce New Standard for Breast Cancer

TransCelerate BioPharma Inc.(“TransCelerate”) is a non-profit organisation dedicated to improving the health of people around the world by accelerating and simplifying the research and development (R&D) of innovative new therapies.The Clinical Data Interchange Standards Consortium (CDISC) is a 501(c)(3) global non-profit charitable organisation that streamlines research and enables connections to healthcare through the development of clinical research data standards.

The need to rapidly and efficiently share new data within clinical research is one of the key initiatives within the world of clinical trial innovation and efficiencies. One of the major steps forward is the announcement CDISC and TransCelerate made earlier this year regarding the open availability of a new CDISC Therapeutic Area Standard for Breast Cancer.

“In order to optimize the care of any patient, we need to have a common set of information that is reliably collected on every one,” stated Dr. Laura Esserman, University of California San Francisco breast cancer surgeon and one of Time magazine’s top 100 most influential individuals in the world. “The CDISC standards will help us to ensure that we are all using a common language, which will then usher in an era where we can automate quality improvement, trial matching, seamless integration of data into trials, and streamline the process of improving the care, survival, and quality of life of our patients.”

For the full article please visit : http://www.prweb.com/releases/2016/05/prweb13423521.htm

20 Jul 2016
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GlaxoSmithKline doing study using Apple’s ResearchKit

GlaxoSmithKline (GSK) has been on the forefront of research innovation and this is no exception. By using Apple’s ResearchKit, London-based GSK are aiming to reduce research costs and improve overall efficiency in terms of data accuracy and patient recruitment. Phase IV observational trials, such as this one, can take months or even years to recruit and enroll patients, said Rob DiCicco, head of Glaxo’s clinical innovation and digital platforms group. “Certainly you’ve also taken out the site costs, and the costs of having nurses and physicians explaining the studies to them and recording information.” He further mentioned that he hopes that the data from the arthritis study will help inform future clinical trials.

“Apple is saying ‘let’s make it easier for you to use our products so that consumers can become more dependent on them,’” said Yuri Teshler, an analyst at Moor Insights and Strategy. Apple’s ability to encourage users to track their health and wellness, he said, will attract insurance companies and other health-care payers in the $4.6 trillion U.S. health-and-fitness industry. “Eventually you’re going to see payers rewarding you for managing your fitness and Apple is going to be in the business of delivering information that payers need.”

For the full article please visit : http://www.bloomberg.com/news