Aptiv Solutions Presents to FDA Staff on ADDPLAN® Adaptive Clinical Trial Software, Launches e-Learning Series for All Stakeholders

Reston, Virginia, June 5, 2013 – Aptiv Solutions, a global biopharmaceutical and medical device development services company and leader in adaptive clinical trials, completed a comprehensive presentation on applications of its ADDPLAN® software for more than 50 staff members at the FDA’s drug, biologic, and medical device divisions. Widely used for the planning, simulation and … continue reading

IEC 60601-1 3rd Edition Deadline One Month Away

The upcoming transition to the Third Edition of the IEC 60601-1 standard for electrical medical devices is fast approaching. June 30, 2013 represents the deadline for meeting the requirements of this new standard, which affects all medical device companies producing products that make use of electricity or electrical systems. The International Electrotechnical Commission (IEC) has … continue reading

Tufts CSDD Study Finds Adoption of Adaptive Clinical Trial Designs Is Increasing

Report Shows Growing Acceptance by Pharmaceutical Companies and Regulatory Agencies Reston, Virginia, May 23, 2013 – Aptiv Solutions, a biopharmaceutical and medical device development services company and pioneer in adaptive clinical trial design, simulation and execution, announces publication of a Tufts Center for the Study of Drug Development (CSDD) report on the adoption and impact … continue reading

Aptiv Solutions to Deliver Keynote at University of Tokyo Conference on Adaptive Clinical Trials

Reston, Virginia, May 7 2013 – Aptiv Solutions, a biopharmaceutical and medical device development services company and pioneer in adaptive clinical trial design, simulation and execution, announces its participation in a prestigious conference on adaptive clinical trials, held at the University of Tokyo on May 10th 2013. The keynote lecture will be delivered by Professor … continue reading

Aptiv Solutions Significantly Expands Its Global Medical Device Expertise With Multiple Key Appointments In Europe

Reston, Virginia, May 2, 2013 – Aptiv Solutions, a biopharmaceutical and medical device development services company and pioneer in adaptive clinical trial design, simulation and execution, announces a significant expansion of its medical device research capabilities in Europe. Most notably, the company announces the appointments of Mr. Bernard Sweeney as Senior Vice President, Medical Devices … continue reading

Aptiv Solutions Establishes Adaptive Center of Excellence and Dose-Finding Consortium to Meet the Growing Needs of Pharma Customers

Reston, Virginia, April 18, 2013 – Aptiv Solutions, a biopharmaceutical and medical device development services company, and the leader in adaptive clinical trial design, simulation and execution, announced today the establishment of the Adaptive Center of Excellence (ACOE). The ACOE is a further development of the growing relationship that Aptiv Solutions has as a strategic … continue reading

Aptiv Solutions Further Strengthens Its Adaptive Trials Expertise With The Appointment Of Parvin Fardipour, PhD

Reston, Virginia, March 21, 2013 – Aptiv Solutions, a biopharmaceutical and medical device development services company, and the leader in adaptive clinical trial design, simulation and execution, announced today the appointment of Parvin Fardipour, PhD to the role of Vice President of Adaptive Clinical Trials.  She will work with sponsors to identify opportunities for applying … continue reading

Executive Roundtable on Adaptive Design Trials Identifies Key Factors that Dramatically Increase Development Efficiency and Productivity

Reston, Virginia, February 28, 2013 – Aptiv Solutions, a biopharmaceutical and medical device development services company, and the leader in adaptive clinical trial design, simulation and execution, reports on the key findings arising from an Executive Roundtable, facilitated by  the Tufts Center for the Study of Drug Development (CSDD) on ‘Leveraging Adaptive Trial Designs to … continue reading

Aptiv Solutions Reaches First Milestone in Delivering New Platform for Model-Based Dose-Finding Trials (ADDPLAN® DF)

Reston, Virginia, February 7, 2013 – Aptiv Solutions, a biopharmaceutical and medical device development services company, and the leader in adaptive clinical trial design, simulation and execution, announces the completion of a key milestone in the development of a new platform for phase Ib and II adaptive design clinical trials. Both regulatory agencies and the … continue reading

Aptiv Solutions Launches Q&A Video Series on Adaptive Clinical Trials

Aptiv Solutions announces the launch of a “Question & Answer” video series featuring Aptiv Solutions experts speaking about types of adaptive design, their benefits, requirements for effective execution, regulatory acceptance and perceived barriers to wider adoption across industry.  The videos feature Scott Gottlieb interviewing Patrick Donnelly, Chairman & CEO of Aptiv Solutions, Luis Gutierrez, Chief … continue reading

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