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Europe’s PRAC Explained 26 Aug 2013 | 05:55 pm
The European regulatory approval system is complex, relying on a combination of centralised and national agency resources with 7 advisory committees established under the European Medicines Agency (EM...
Aptiv Solutions Appoints Patricia Monteforte, CRO Executive and Entrepreneur, as President of Trio Clinical Resourcing 21 Aug 2013 | 12:40 am
Reston, Virginia, August 20, 2013 – Aptiv Solutions, a global biopharmaceutical and medical device development services company and leader in adaptive clinical trials, announced today the appointment ...
Aptiv Solutions Senior Vice President, Vlad Dragalin, Elected Fellow of the American Statistical Association 21 Aug 2013 | 12:40 am
Reston, Virginia, August 20, 2013 – Aptiv Solutions, a global biopharmaceutical and medical device development services company and leader in adaptive clinical trials, announces the election of Vlad D...
FDA Releases Medical Device Appeals Process Guidance 8 Aug 2013 | 05:55 pm
Medical device companies that have seen their 510(k) applications rejected by the FDA had reason to cheer this past month after the FDA released a guidance document that outlines the previously-opaque...
Competition Between Medical Device Companies And Pharma Could Stimulate Early Stage Acquisition Strategies 1 Aug 2013 | 05:55 pm
It’s a familiar story in the pharmaceutical industry: larger companies seek to fill their product pipelines by purchasing start-ups that can deliver promising drugs backed by strong clinical evidence ...
FDA Encourages Adaptive Designs For Antibacterial Development 25 Jul 2013 | 05:55 pm
Regulators are continuing to advocate adaptive clinical trial design for a wide range of therapeutic areas. The latest push from the FDA for adopting adaptive trial design relates to antibacterial dru...
JSM 2013: Aptiv Solutions Experts to Present on Adaptive Trial Design 22 Jul 2013 | 05:55 pm
Aptiv Solutions will present at two symposia at JSM 2013, the annual conference of the Joint Statistical Meetings, held at the Palais des congrès de Montréal, August 3 – 8. The symposia will address k...
FDA To Require Premarket Approval For Automated External Defibrillators 15 Jul 2013 | 05:55 pm
Any medical device that is widely used by the general public in an emergency situation is likely to fall under a higher degree of scrutiny than those found exclusively in a clinical setting. Such is t...
Adaptive Trial Design Gains Priority For IND Submissions 3 Jul 2013 | 05:55 pm
There are many benefits to adopting adaptive trial design in Phase II and Phase III clinical investigations, but the FDA has recently added yet another major incentive for drug companies to consider t...
American Cardiac Medical Device Approval Times Four Years Behind EU 1 Jul 2013 | 05:55 pm
Medical device manufacturers who market products in the cardiac health segment are all-too familiar with the significant gap between FDA medical device approval times and those found in Europe. Reuter...
