HighPoint Blog

Are your practices for handling TMFs compliant with the new GCP requirements from ICH E6 (R2) coming into effect June 14?

Background for ICH E6 (R2)

The ICH GCP E6 regulation was introduced in 1996 when clinical trials were largely run on paper. Since then, the following trends have significantly increased:

• the scale, complexity, and cost of clinical trials • the degree of outsourcing for... Read More

Companies contemplating moving their unstructured data to the cloud are often concerned with the security of the platform and the cloud provider: managing cyber-risk to protect digital assets. Contrary to those concerns, the evidence shows the data centers and security processes of cloud providers are, in fact, far more hardened than any corporate data center. Greatly eliminating this security...

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Market Access is becoming more and more challenging. This is irrespective of drug classes and new technologies. Payers are applying the same scrutiny on orphan drugs as on drugs for primary care. This is driven by increased budget constraints in healthcare systems and the heterogeneity of reimbursement systems worldwide.

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Special thanks to co-writer Heenal Patel, Manager Pricing & Contracting. 

In United States' managed care contract administration, price protection is a strategy frequently used on executed contracts.

In simple terms, price protection calculates a ceiling price, safeguarding a price point as price increases occur. As drug prices rise, a rebate is issued for anything above the maximum price...

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