Category: Clinical Development

12 Jul 2017
ISTH

TCD attending the ISTH 2017 Congress in Berlin, Germany.

 

The Largest International Meeting of the Thrombosis and Hemostasis Community, the ISTH 2017 Congress, is currently taking place at the CityCube/Messe Berlin in Germany. It is the 26th Biennial Congress and will run until Thursday, the 13th of July. The ISTH 2017 Congress is the foremost global meeting in thrombosis, hemostasis and vascular biology. The event is organised by the International Society on Thrombosis and Haemostasis and theme of this year’s congress is Transcending Scientific Boundaries.1

Japie van Tonder, Director, Global Data Services at Triclinium Clinical Development (TCD), is presenting a poster at the congress: Comparison of the Injection Site Reactions Elicited by Two Subcutaneously Injected Heparins, Nadroparin Calcium and Enoxaparin Sodium [J.J. van Tonder, S. Mathijs, J.M. Dippenaar, O. Greeff (South Africa)].

The International Society on Thrombosis and Hemostasis (ISTH) is a global not-for-profit membership organisation advancing the understanding, prevention, diagnosis and treatment of thrombotic and bleeding disorders.1

The congress started on Saturday the 8th of July with the 63rd Annual ISTH SSC Meeting, followed by The ISTH Congress opening ceremony on Sunday evening. More than 8,000 scientists, clinicians and leading experts on thrombosis, hemostasis and vascular biology come together from around the world to present the most recent advances, exchange the latest science and discuss the newest clinical applications designed to improve patient care.2

The scientific part of the congress features 131 invited speakers, including eight plenary lectures by front-line scientists and 84 state-of-the-art lectures by leaders in their respective fields. The congress offers 39 abstract symposia with an introductory review lecture, followed by oral presentations of top-scoring abstracts.2

A late-breaking session was held on Tuesday highlighting important and timely results from clinical trials, with poster presentations taking place from Monday through to Wednesday. Overall, more than 3,000 abstracts will be presented as oral or poster presentations. The congress closes on Thursday at noon with a session on the highlights of ISTH 2017. 2

For more information on the congress visit: http://www.isth2017.org/ and to receive news and updates visit http://isthcongressdaily.org/

 

  1. http://www.isth2017.org/
  2. http://www.isth2017.org/uploads/7/2/6/0/72600829/final_program_2017.pdf

 

02 May 2017
EOH-image

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

31 Jan 2017
MENA_Registered

TCD MENA officially registered as CRO in Egypt

We are proud to announce that TCD MENA is now officially registered as a CRO in Egypt. Complementing TCD SA’s long-standing outreach into sub-Saharan and West Africa, TCD MENA was recently established in Heliopolis, Cairo to extend the provision of TCD’s clinical development services to clients looking to conduct research in the Middle East and North Africa (MENA) region.

The TCD MENA team has extensive clinical research experience in managing global clinical trials with sites in Egypt and the MENA region, as well as managing bioequivalence studies accepted by WHO, FDA and EU. Their expertise covers various therapeutic areas, including Oncology, Hepatology, Internal Medicine, Gynaecology and chronic diseases with strong relationships with KOLs across Egypt and the MENA region. Services include Regulatory Affairs, Clinical Operations, Project Management, Pharmacovigilance, Data Management, Biostatistics and Medical Writing.

We at TCD South Africa are excited about this long-standing partnership with TCD MENA, and in walking this road for the benefit of humanity.

23 Dec 2016
Africa People

Gates Foundation to Invest in HIV Prevention Device

“The Bill & Melinda Gates Foundation is investing as much as $140 million to support development of a tiny implantable drug pump it believes could help prevent people in sub-Saharan Africa and elsewhere from becoming infected with HIV, the virus that causes AIDS. The matchstick-size pump is being developed by Intarcia Therapeutics Inc., a closely held Boston biotechnology company. It can hold six or 12 months’ supply of medicine and is designed to deliver microdoses continuously to patients, ensuring they stay on the treatment.” as reported by the Wall Street Journal (http://www.wsj.com/)

“If we don’t find a way to prevent infection, we’re going to wind up with more people infected in that part of the world than we have now,” said Emilio Emini, director of the HIV program at the Gates Foundation. But “its real-world effectiveness is much lower than that because you have to take a pill” every day and getting healthy people to do so is difficult, Dr. Emini said. That is what makes Intarcia’s pump so attractive, he said. “You put it in and you forget it,” he said, likening it to long-acting forms of contraception. “You can immediately imagine how it could be applicable.”

Read the full article here : http://www.wsj.com/articles/gates-foundation-to-invest-up-to-140-million-in-hiv-prevention-device-1483023602

17 Dec 2016
TCD MENA

TCD MENA: The family grows

What started one year ago as a dream, became a reality on 1 December 2016 when TCD MENA opened its doors in Heliopolis, Cairo as a full service CRO, serving the Middle-East and North-Africa region.

Being part of the TCD Group (www.tcd-global.com), our reach now extends from the Southern tip of the continent, to the North and the Middle-East. In the words of Dr. Hanaa Abdel-Maguid, managing director of TCD MENA: “Having been a sponsor of clinical trials for many years, I understand the needs of sponsors in a time when there are significant economic constraints globally. Part of our mission will be to convert these sponsor needs into innovative solutions that will compliment and support R&D objectives.”

The words of Eric Hoffer ring true: “In times of change, the learners shall inherit the earth, while the learned will find themselves perfectly equipped to manage a world that no longer exist.” As a learning organisation, the TCD Group will remain responsive to global trends and changing customer needs.

08 Dec 2016
Researchers work on November 15, 2012 in Loos, northern France, in a laboratory of French biopharmaceutical company Genfit, specialised in the development of innovative therapeutic and diagnostic solutions for prevention and treatment of cardiometabolic disease and related disorders. AFP PHOTO PHILIPPE HUGUEN

Results from a TCD study : comparing generic Meropenem (Mercide®) with innovator brand (Meronem®)

Triclinium Clinical Development aided in the analysis and reporting of an in-practice study aimed at demonstrating therapeutic and bio-equivalence between a generic brand of meropenem and the innovator. The study demonstrated similar ex vivo efficacy and in vivo pharmacokinetics for the products under observation. Results suggest that the products are clinically interchangeable based on registration status, as well as bioassay results. A slightly higher observed generic meropenem AUC (approx. 4% higher) was observed, which is clinically acceptable due to a large therapeutic index.

For more in-depth reading, click here

22 Nov 2016
(Science Photo Library/Newscom)
ISA-INCR-041416-Newscom 
Scientist preparing blood sample for clinical testing in a laboratory. (Newscom TagID: splrfphotos063878.jpg) [Photo via Newscom]

AbbVie pangenotypic combination shows promising results for Hepatitis C

AbbVie is running three large clinical research studies currently where a combination of glecaprevir and pibrentasvir has cured at least 98% of people with hepatitis C.

“The results we announced today bring us closer to providing a potential pan-genotypic, once-daily treatment option with 8 weeks of therapy for people living without cirrhosis and who are new to treatment,” said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. “With our registrational program nearing completion, we’re on track to submit our next generation, pan-genotypic regimen to regulatory authorities by the end of this year in the U.S. and early 2017 in the European Union and Japan.”

For the full article please visit : https://news.abbvie.com/news/eight-weeks-treatment-with-abbvies-investigational-pan-genotypic-regimen-glecaprevirpibrentasvir-gp-achieved-high-svr-rates-across-all-major-genotypes-chronic-hepatitis-c.htm#.WDR6wO5Nj68.link

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

18 Nov 2016
How-3D-Printing-Will-Affect-The-Healthcare-Industry-850x400

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/]

09 Nov 2016
StockSnap_0XWO70HDZB

TB Alliance partners with PepsiCo

TB Alliance is a not-for-profit organisation dedicated to the discovery and development of better, faster-acting, and affordable tuberculosis drugs that are available to those who need them. The organisation recently announced a partnership with beverage company PepsiCo with the sole purpose of improving the taste of treatment for children with TB.

“At PepsiCo, we saw a unique opportunity to leverage our R&D talent and flavor expertise to help improve the palatability of certain TB medicines,” said Dr. Mehmood Khan, Vice Chairman and Chief Scientific Officer, Global Research and Development, PepsiCo. “In collaboration with the TB Alliance team and others, we are hopeful that we can identify formulation changes that will make it easier for caregivers to administer TB medicines to children. Our work together has the potential to significantly improve the care and well-being of many TB patients and move us one step closer to the goal of eradicating TB in children.”

For the full story please visit : http://www.tballiance.org/news/tb-alliance-partners-pepsico-advance-fight-improved-medicines-children

[source : http://www.tballiance.org/]

04 Nov 2016
Merck-Logo.svg

Merck’s new Alzheimer’s drug shows positive results

Merck’s new new Alzheimer’s drug (currently being evaluated in two Phase 3 clinical trials) has shown positive results in targeting the most visible sign of the disease in the patient’s brain. These results have had a very positive impact on the patient community suffering from Alzheimer’s as this could possibly be the first new treatment for the disease in more than a decade.

“We believe this research has the potential to contribute important evidence regarding the amyloid hypothesis, a leading scientific theory for what causes Alzheimer’s disease, and we look forward to seeing the data from our ongoing Phase 3 clinical trials,” Dr. Michael Egan, vice president of clinical development neurosciences at Merck Research Laboratories, said in a statement.

For the full story please visit : http://www.marketwatch.com/story/mercks-alzheimers-drug-data-fuel-hopes-for-new-treatment-2016-11-03

[source: http://www.marketwatch.com/]