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PRODUCTS: INNOVATION MANAGEMENT

Medical Affairs

ideaPoint: Medical Affairs

Configurable software to adapt to any company’s SOP’s for managing the highly-regulated process of evaluating, approving, tracking, and reporting on Medical Affairs Programs in a secure and compliant manner.

Investigator Initiated Studies

ideaPoint delivers a unified system to help our customers manage compliant and successful, local and global Investigator Initiated Studies programs.

Our customers choose ideaPoint software to support their end-to-end IIS evaluation and management processes - from the submission and assessment of IIS requests through the management and tracking of approved studies - because it enables them to:

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Comply with evolving regulatory guidelines and reporting requirements

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Vet potential research partners and study proposals

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Select and support the studies that are most likely to succeed

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Track and report on all decision points and study-related activities, milestones and contract obligations

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Engage the investigator throughout the lifecycle of the study

Medical Education Grants

Configured to handle any type of grant request or application, ideaPoint delivers a comprehensive Grant Management solution to the global enterprise. ideaPoint software centralizes, enriches and enables knowledge sharing around the whole Grant Management process, from fielding and evaluating requests on through to tracking funding payments and managing relationships.

With ideaPoint, our customers have a secure and user-friendly solution through which to scout, evaluate, invest-in, track and manage Grant requests and applications.

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Early Access Programs

Managed Access Programs (including Named Patient, Expanded Access, Early Access, Compassionate Use and Temporary Authorisation for Use (ATU) programs), are being designed to provide patient and physician access to investigational drugs outside of clinical trials and prior to marketing approval and launch. These programs are improving access to drugs for the fulfillment of unmet patient needs in an ethical way.

The rapidly evolving legislative environment (“Right to Try Act”- USA, “21st Century Cures Act”- USA, “Early Access to Medicines Scheme (EAMS)”- UK, etc.), will eventually force all drug manufacturers to publicly disclose their policies and procedures for making such drugs available to patients who are in need. ideaPoint software helps companies manage compliant and successful, local and global Managed Access Programs so that companies are providing the ability to grant access to the drug(s) while approvals are sought in various countries. Some additional benefits to a well-run and compliant

Managed Access Program supported by ideaPoint web-based software include:

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Access to documentation for HCP’s and Patients

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Access and screen physicians, and develop a network of physicians who have early experience with the drug

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Track and report on all decision points and program-related activities, milestones and contract obligations

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Comply with evolving country-specific regulatory guidelines & reporting requirements

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Consistency but with flexible approach as program scope will constantly change

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Maintain a high-level of information security

Clinical Trial Data Sharing

As Researchers continue to search for treatments and cures to some of society's biggest medical challenges, the need to seek scientific insights that may lead to potential improvements in patient care has become a pressing issue. ideaPoint has been a leader in technology solutions to support responsible clinical trial data sharing since January 1, 2014.

ClinicalStudyDataRequest.com (CSDR) is a consortium of clinical study sponsors and funders. It is a leader in the data sharing community inspired to drive scientific innovation and improve medical care by facilitating access to patient-level data from clinical studies.