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Regulatory agencies such as the FDA will balance the expedited approval of beneficial new drugs or devices against potential serious adverse events that may occur once products are distributed across a wide market. In order to accomplish this they may require the manufacturer to put in place a Risk Management System in an effort to mitigate possible serious adverse events. These programs may also be required after the product has been approved as a result of new evidence as to the products performance in the market place.

A pharmaceutical/device Risk Management Action Plan (RiskMAP) can range from standard labeling to strict limitations on prescribing and can require long term program management.

Tii’s solution for establishing a (RiskMAP) consists of three components to address key regulatory concerns. They include

• Education and Outreach
• Surveillance and Guidance
• Restricted Access

Education and Outreach

For some products, the FDA may determine that the package insert is not enough to ensure important safety information gets noticed. Regulatory authorities may require additional methods to be employed to educate those impacted about potential risks as well as provide documentation that such measures have taken place. In this situation a proactive education and outreach program needs to be employed to insure the message gets communicated to physicians, pharmacists, patients, consumers and caregivers.

Tii’s Education & Outreach programs can target these stakeholders through a variety of mediums including the web, health and wellness news, support communities and through the use of interactive health management tools. Online communities can be set up through collaborative portals and special events allow consumers to participate in real-time discussions with experts and people who share similar health conditions or concerns. Tii’s Education & Outreach programs will ultimately help stakeholders understand if patients may be at an elevated risk and educate them on proper usage of your product.

Guidance and Surveillance

Education and Outreach is only one component in managing risk. Toxicology tests or clinical trials may indicate the potential for rare effects due to existing conditions, concomitant medications or long-term use. It may be imperative to know if your new product is being taken as prescribed; or if physicians are heeding the warnings in the latest Dear Health Care Professional letter.

Tii Guidance and Surveillance programs provide the infrastructure to proactively gather information on how your product is being used and tolerated by patients in a real-world setting. Tii allows physicians, patients and/or pharmacists to register for your safety program on the Web or by telephone. From there, Guidance & Surveillance may include:

• Outbound calls or emails to physicians and pharmacists to confirm receipt of a Dear Health Care Professional letter and to ensure understanding of risks and appropriate prescribing conditions
• Interviews with patients to determine their understanding of proper use and to solicit adverse events proactively
• Certification programs to train practitioners on contraindicated conditions and monitoring for adverse events

Restricted Access Programs

Some products need stringent interventions to maintain a favorable benefit/risk ratio. Tii designs and implements Restricted Access programs that ensure a product is prescribed by qualified physicians, dispensed by eligible pharmacies, used by appropriate patients, and shipped by authorized distributors.

Tii restricted access programs are configured to your product’s requirements. Patients, physicians, pharmacists, and/or distributors register to use, prescribe, dispense or ship your product. Information such as patient history, concomitant medications or lab test results are collected to confirm eligibility of patients to receive the drug. Your Restricted Access program can then be configured to include one or more of the following:

• Informed consent, obtained via phone, digital fax, Web or e-mail, and stored in the online registry to document that physicians and patients are aware of potential adverse events and the importance of monitoring for and reporting them
• Creation of a unique patient identification number and prescription number in the online registry, which the pharmacist compares to verify eligibility before dispensing the drug
• Creation of a unique physician or hospital pharmacy identification number in the online registry, which authorized distributors of your product check to ensure those entities are certified to receive the drug

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