Tag: medical device

Clinical Research: Phase 1 - Phase 4

8 Steps to Jump-Starting a CEC

In our previous CECs blogpost, we reviewed why Clinical Endpoint Committees (CECs) are so crucial for successful trials today. But just how do sponsors establish and operate a CEC? It’s a complex process that can be broken down into these eight key steps: 1. Understand the deep level of commitment required in putting a CEC together....

Consulting

CECs: What Are They and Why Does Your Trial Need One?

Also called Endpoint Adjudication Committees, Clinical Endpoint Committees (CECs) are an increasingly common component of drug development and medical device evaluation. A CEC is a centralized decision-making body for safety and efficacy endpoints. The goal of a CEC is to standardize outcomes and optimize data quality, ultimately driving study success. A CEC addresses the challenge...

Consulting

21st Century Cures Act: Changes to Medical Device Regulation in the U.S.

In December 2016, the United States passed an important piece of regulatory legislation called the 21st Century Cures Act. These FDA regulations cover multiple types of clinical research but include some specific provisions for medical device development. In contrast to the regulatory reform seen in the EU — which includes a much-needed increased emphasis on...

Consulting

7 Sponsor Responsibilities in Medical Device Clinical Trials

What are sponsors in medical device trials responsible for? Pretty much everything. Seriously. Clinical trials for medical devices involve many complex “moving parts” in the form of different groups of investigators, suppliers, contractors, committees, and other organizations. For a successful trial, sponsors must make sure each works together in harmony. Roles of a Sponsor The seven key...

Consulting

European Medical Device Regulations: Coming Changes to the Regulatory Landscape in the EU

No matter your role in the industry, you may have heard about the significant upcoming changes to European medical device regulations. But just what are they? What’s the proposed implementation timeline? Here’s an overview of the proposed legislation, as well as a tentative schedule of important dates. Getting Up to Speed In June 2016, the...

Medical and Regulatory Affairs

ISO Guidelines for Medical Device Trials: Ethical Considerations and Informed Consent

With increasing demands for evidence of clinical efficacy and safety, applying sound research practices to medical device development is crucial for a product’s success. The Need for High Standards in Study Design When bringing a new medical device to the market — or even reevaluating an existing product — device companies must answer to: Regulators placing greater scrutiny on...

Consulting

4 Ways a Target Product Profile Enhances the Medical Device Development Process

A target product profile (TPP) is a strategic process tool that streamlines medical device development through cross-functional strategic alignment. It’s a living document that defines the value proposition and key differentiators of an intended commercial product while assisting in product development strategy. A TPP may take a lot of time and resources to craft, but it’s a strategy that promises a major...

Clinical Research: Phase 1 - Phase 4

The 5 Components of an Effective Target Product Profile

A target product profile is a document that presents a polished explanation and aggregation of all relevant information needed in validating product development. This common template can be used for all products across a company portfolio to guide and align regulatory, preclinical, clinical, marketing, and health economic outcomes and reimbursement strategies. The concept of the TPP was originally developed...

Quality

The Trends Reshaping Medical Device Trials: Attend Our Webinar on Nov. 2

DURHAM, N.C., OCTOBER 27, 2016 — Medical device and diagnostic companies are conducting more clinical trials than ever, a trend that’s giving rise to new procedures and best practices for studies that differ in many ways from pharmaceutical trials. Register for this webinar focused on the evolution of device clinical research on Wednesday, November 2....