Overcoming CDISC Data Conversion Challenges for FDA Submissions

In order to help standardize clinical research data across the industry and expedite the drug approval process, the FDA mandated in 2016 that all clinical trial data for a drug program must be submitted to the FDA in CDISC data standard format.  Therefore, it is highly important that sponsors

March 16th, 2018|

Achieve High Quality Adjudication Results with Clinical Review

The success of an Endpoint Adjudication Committee (EAC) is highly dependent upon the quality of the information provided to the adjudicators. Sponsors can greatly improve the clinical data presented to adjudicators by adding clinical oversight to the adjudication process. Collecting high quality source data from investigative sites can sometimes

January 23rd, 2018|

DMC’s Role of the Reporting Statistician

The primary goal of the Data Monitoring Committee (DMC) in a drug development paradigm is to evaluate the ongoing safety of a study or a program (i.e., group of studies) and determine if there are any glaring safety concerns for the patients. If safety concerns become apparent, the DMC

September 28th, 2017|

New FDA Requirement for ClinicalTrials.Gov

Recently the U.S. Department of Health and Human Services published their Final Rule on Clinical Trials Registration and Results Information Submission (Section 801 of the Food and Drug Administration Amendments Act, more commonly referred to as FDAAA 801) which was effective January 18, 2017. This new final rule requires

January 25th, 2017|

DMCs and EACs – Where to Draw the Line in Communications

Recently there’s been an influx of companies sharing their views on the importance of Data Monitoring Committees (DMCs) and the roles they share with Endpoint Adjudication Committees (EACs). For example, one company recently published a whitepaper with the viewpoint that a DMC and EAC should share opinions in a

January 19th, 2017|

The Importance of Independence in Expert Committee Management

In today’s clinical development landscape, more and more clinical trial designs are including a specialized oversight component on accumulating data that utilizes medical and/or statistical experts who operate within a committee structure according to charter-defined rules and procedures. Two of the most popular types of Expert Committees used in

October 18th, 2016|

Why Drug Development Companies Need To Implement Safety Assessment Committees

In December 2015, the FDA released a new draft Guidance for Industry related to IND Safety Reporting. The guidance states that due to the critical need to detect and report serious adverse events as early as possible, the FDA recommends that sponsors form a Safety Assessment Committee to use

August 25th, 2016|

Casting Health Care Providers

With summer movie season in full swing, one must consider the process by which movie casting directors match the right stars to their intended films. This challenging task, which can ultimately make or break the box office and critical success of a film, is not unlike the process by

July 14th, 2016|

Staying Compliant: Spend Reporting in the Modern Pharmaceutical World

In order to stay compliant, pharmaceutical companies must be more diligent than ever in tracking their financial payments to the doctors that work for them. This is especially true since the Physician Payments Sunshine Act, informally known as the Sunshine Act, was established in 2010 to promote transparency surrounding

May 12th, 2016|

Unique Challenges for Medical Device Clinical Trials

From glucose meters to artificial heart valves, the medical device industry produces a broad range of diagnostic and therapeutic devices for the treatment and prevention of numerous patient health conditions. Medical Device Approval Process Device manufacturers are required to register annually with The U.S. Food and Drug Administration (FDA) and

February 19th, 2016|
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