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Flashcards in Background Deck (9)
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1

Who

Any company running a clinical trials

2

Sponsors include:

Biotech and Pharmaceutical Companies

3

Clinical Research Organizations are:

Companies Outsourced by Sponsors to Run the Study

4

We target people involved in:

planning, activation and operations of a clinical study

5

Titles:

• Clinical Operations
• Feasibility
• Site Selection
• Site Activation
• Clinical Development/Clinical Management
• Informatics

6

Why

The cost of a clinical trial is directly impacted by the amount of time the study takes to plan and execute.

7

Protocol Design

quick recruitment
safety
operational efficiency
appropriately measured results.

8

Protocol Design Assistance

Users can view all historical protocols that are similar to their own to evaluate what has been successful in the past and what has not. Users can examine which competitors have had the most successes and failures with protocols similar to theirs and benchmark their own design against others. They can see why similar studies failed to determine if the protocol design led to safety, drug availability, or recruitment issues.

9

Site Selection & Recruitment

2