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Kaplan EduNeering Introduces DocMinder

New online solution automates compliance for consulting arrangements between life science companies and doctors

October 25, 2007 — Princeton, New Jersey — Kaplan EduNeering, a leading provider of knowledge management solutions to assure regulatory compliance and improve business performance, has introduced DocMinder^S^M, its newest online compliance management solution. DocMinder manages and documents the relationships between life science companies (pharmaceutical, medical device and biologics) and the doctors and other consultants with whom they routinely contract.

DocMinder is designed to help life science companies comply with laws and standards such as anti-kickback and anti-bribery mandates, which are currently being actively enforced by the Department of Justice and state prosecutors, among others. “Given the recent spate of Corporate Integrity Agreements put in place between the government and several medical device companies, it’s clear consulting arrangements with health care professionals are getting close scrutiny,” said Jason B. Meyer, Chief Legal and Compliance Officer at Kaplan EduNeering. “DocMinder puts in place a set of automated procedures that address these kinds of compliance risks.”

Here are some of the requirements in both the law and recent Corporate Integrity Agreements that DocMinder can meet:

Companies must establish databases detailing each of their financial arrangements with physicians and other consultants, including any remuneration the companies pay;
Every consulting arrangement must be documented in a written contract, and involve payment for no more than a fair market value;
Databases must track the work performed by consultants and facilitate monitoring of whether those arrangements are in compliance;
Reporting issues, such as mandates that companies disclose on their websites the name of each consultant and what the consultant has been paid.

DocMinder helps sponsors achieve this level of compliance by automating the workflow of creating and maintaining a consulting relationship, from project authorization and consultant selection, to approvals of deliverables and payment. More than a dozen compliance safeguards are integrated into DocMinder, which can trigger an alarm when a contract-specific deadline approaches or a potential violation is identified. Meyer added, “Beyond the clear compliance advantages provided by this new solution, DocMinder offers management solid visibility and control over a company’s consulting arrangements.” In addition, DocMinder is highly configurable to meet the unique business needs of medical device, pharmaceutical, and biologics companies.

DocMinder may be linked with Kaplan EduNeering’s ComplianceWire^®,a fully integrated, Part 11 validated knowledge management system designed to meet the high-security needs of organizations regulated by the US Food and Drug Administration (FDA). ComplianceWire enables the web-based distribution, validation of receipt, testing and documentation of training. It is employed by the FDA to provide training for more than 30,000 investigators. ComplianceWire also is used by more than 100 leading life science organizations worldwide as a key component of their regulatory compliance programs.