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PRODUCTS: ideaPoint

Evidence Generating & Medical Affairs Programs

Evidence Generating & Medical Affairs Programs

ideaPoint software helps our customers manage successful, local and global medical affairs evidence generating programs. These include Investigator Initiated Studies, Grants, Expanded Access, and many other programs. Scroll down for details.

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Investigator Initiated Studies

There are several different terms used for Investigator Initiated Research.  (Also referred to as Investigator Sponsored Studies Investigator Sponsored Trials, or Investigator Sponsored Research.  Whether you run an IIS, IIT, ISS, IST, or ISR program, ideaPoint software will support the end-to-end submission, evaluation, and management processes with detailed tracking and reporting. 

  • Communicate directly with healthcare community via a branded Portal

  • Capture all necessary data and supporting documents from PI

  • Review and track requests using a collaborative toolset

  • Flexibility to comply with evolving regulatory guidelines

  • Report on spend, drug and product shipments, and patient enrollment

Grants

ideaPoint software centralizes, enriches, and enables knowledge sharing around the entire Grant Management process, from fielding and evaluating requests to tracking approvals, funding payments and managing relationships.  Pharmaceutical and Biotech companies use ideaPoint for Medical Education Grants, Research Grants, Fellowships, Sponsorships and other grant programs to: 

  • Comply with evolving regulatory guidelines and reporting requirements

  • Vet potential Requestors and Grant proposals

  • Select and support the Grants that are most likely to succeed

  • Engage the Requestor throughout the lifecycle of the Grant

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

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Expanded Access Programs

Expanded Access Programs (including Named Patient, Managed Access, Early Access, Compassionate Use and Temporary Authorization for Use programs) provide patient access to investigational drugs prior to marketing approval and launch. These programs are improving access to drugs for the fulfillment of unmet patient needs in an ethical manner. 

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, Expanded Access Programs so that companies are providing the ability to grant access to the drug(s) while approvals are sought in various countries.  

  • Screen requestors and develop a network of physicians who have early experience with a product

  • Streamline and accelerate the review process to ensure patients receive the timely care necessary

  • Centralize the request process to make certain that all requests are managed appropriately, to create a single source of truth

  • Detail tracking and reporting of requests, approvals, drug shipment and results