Monthly Archives: November 2013

Why Get Clinical Trial Data Feedback in Real-Time?

Real Time Data ManagementClinical trials data management is essential for medical and clinical researchers, doctors who assist with pharmaceutical drug development and C-suite decision makers in pharmaceutical drug development. The “3-C’s” of site management include connection, communication, and control.

The value of real-time clinical trial data feedback lies in enabling these medical professionals to attend to each of those “C” actions.  The real-time connection and communication allows pharmaceutical professionals to review incoming trial data in real-time and control its dissemination and implementation in order to support making critical business decisions mid-stream in a project.


Importance of Real-Time Clinical Trial Data Feedback

As professionals working in the ever-changing world of medical research, we know that outdated information is ineffective for making important decisions that are vital to safe health practices. When medical professionals make decisions during prescription drug development, those decisions can affect people’s well-being and even their lives. This is why clinical trials data management must facilitate and implement real-time clinical trial data feedback, to provide the most current information and best practices within pharmaceutical drug development.

Implementing Electronic Data Capture (EDC) as a key strategy for clinical trials data management of real-time clinical trial data feedback assists pharmaceutical professionals in several essential areas:

  • Real-time immediate feedback: Allows for transfer of data in real-time; rapid resolution of discrepancies; reduction of time and costs; acceleration of query management; and      verification and correction of inconsistencies in data in real-time.
  • Up-to-date accessibility of trial information and feedback: Allows for organization of global research data into a single database; provides up-to-date study statistics; enables less time to develop and produce essential statistical reports; and decreases risk of data blinding errors.
  • Safer, higher quality of data: Allows for encryption of data, which prevents any changes, deletions, or modifications; facilitates faster data cleaning processes; and automates editing and discrepancy checking.
  • Integrated safety data: Allows for crucial medical safety reviews regardless of data source’s originating country or time zone.
  • Adverse trends: Allows for tracking and reporting on adverse trends occurring with select pharmaceutical drugs.
  • Ongoing workflow: Allows for workflow to continue on an ongoing basis with real-time data, integrating and updating information as it is received.
  • Cost reduction: Allows more cost-effective means to share and store data, feedback, and other relevant clinical trials information; reduces the number of necessary field monitoring on-site visits; reduces clinical research costs; and reduces cost of introducing new drugs to the pharmaceutical market.

Consider This…Data Stream
Implementation of data standards for real-time information flow within clinical data management:

  • improves efficiency of trials and their relevant feedback;
  • allows for maximum usability of tools
  • enables combining data across clinical studies
  • facilitates collaboration across departments and organizations
  • promotes easier and more effective implementation of the three “C’s” of site management by connecting authorized parties to real-time clinical trial data, communicating clinical trial data, and controlling the safety of clinical trial data and its related feedback.

EDC ButtonOverall, clinical trials data management of real-time clinical trial data feedback has proven to be the most positive and effective way to promote health and safety within the pharmaceutical development process.

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The Value of Developing Generic Drugs

Generic drugs have the same chemical composition and non-active components as their brand name counterparts. Generics are prescribed in the same dosages, are administered in the same forms and act the same ways in the body. The difference to the consumer is the price. Generic drugs usually cost much less than the brand name product.

Generic Drugs

Generic Drugs are produced for all types of indications

Pharmaceutical drug development costs for generics are much lower than for brand name drugs because it is not necessary for them to conduct the extensive studies required of new medicines; they only asses the bioequivalence of their generic product to the brand name product. Producers of generic drugs still make a profit even though they sell their drugs at a much lower price than the brand name product.

Application for pharmaceutical drug development of generics is easier and less costly than for a new drug

When the patent for a brand name drug expires, other pharmaceutical manufacturers may develop their own generic forms of that drug. FDA approval is still required for the production and sale of generics, but this approval is through an Abbreviated New Drug Application, ANDA. It is a much quicker application process as it has has fewer requirements than does an application for a new brand name drug. Thus, the ANDA is faster to review and approve by the office of Generic Drugs.

Here are a few reasons why pharmaceutical drug development for generics is easier and less costly than in the development of new drugs:

  1. The chemical composition of the drug has already been established by the brand name company so there are lower costs incurred for research and development.
  2. Generic companies need only show bioequivalence. They are not required to conduct costly clinical trials to prove the safety of their generic drug or that the drug works in the way it is intended to work. These trials were conducted by the brand name company.
  3. Companies producing generics must prove their product is biologically equivalent to and performs in the same way as the brand name drug. This means the generic version has the same active ingredients delivered into a patient’s blood stream in the exact same manner and the exact same time as does the brand name drug.
  4. The generic drug must not look like the brand name drug. For example, it must have a different color even though its chemical composition must be the same.
  5. When the application is approved, the cost to the generic pharmaceutical company is limited to costs of producing and distributing the generic drug.

Other advantages of pharmaceutical drug development of generics

Generic Tablets in Blister Pack

Generic Tablets in Blister Pack

FDA approval of an application for production of a generic drug signifies that the drug has met the “same rigid standards” required of the brand name drug manufacturer.  The FDA approval of the ANDA signifies the generic has been shown in limited clinical studies to be as safe as the brand name drug and works in exactly the same way.

Pharmaceutical companies that manufacture generics actually receive the benefit of the previous marketing campaigns of the brand name company. The public is familiar with the drug and is comfortable using it. When competition is presented by multiple companies now offering the same drug in just a cheaper version with a generic name, consumers are more likely to demand the less expensive drug.

Got Questions? We have Answers! Contact us at CriteriumBlog@criteriuminc.com