Clinical trials are time-consuming, expensive, and often burdensome on patients. Literature from the past 30 years has identified common patterns of reasons for failing. Trial failures can arise from factors such as: failing to maintain suitable protocols, being unable to follow FDA guidance, complex procedures for participating patients, slow recruitment, lack of efficacy, safety issues, and/or insufficient funding to complete a trial.

BBCR experts provide an understanding of the reasons a trial failed and offer insights to create and execute successful clinical trial management protocols and CRO management.   

The experienced trial management address risks such as:

• Scarce enrollment
• Multiple protocol amendments
• Poor patient retention
• Poor data quality
• Prolonged trial completion timeline
• Poor safety monitor 

Efficiency in clinical trials is essential

BBCR developed the Strategic Clinical Innovation Organization^SM (SCIO^SM) method to secure cost-efficiency and risk management strategies from pre-clinical to market. 

Identified challenges are:

• Ever-changing regulatory environment
• Need for cost-effective clinical research
• Patient-centric trial design
• Cost-accessible Biosimilars
• More drugs for Rare Diseases
• New-tech Medical Devices
• Combination Products
• Precision Medicine

The SCIO^SM method creates a product specific clinical/regulatory strategy as part of the IND or IDE before clinical tactics (CRO) activities start.

A MOST SUCCESSFUL DRUG DEVELOPMENT RELIES ON A STRATEGIC PLAN AS THE BEST VACATION RELIES ON AN ITINERARY

Successful trial management includes oversight, monitoring, and ensuring subjects’ safety, quality data, timelines, and budget.

BBCR’s experienced consultants work with project managers to assess and implement the best site communication and motivational strategies.