Clinical Trials

Record Control for a Regulated World

Record Control for a Regulated World

In a regulated industry, the prevailing posture of regulatory representatives, in my experience, has been “Show me proof.” In fact, the philosophy I’ve heard repeated by regulators is “If it wasn’t documented, it didn’t happen.”

EU MDR SSCP’s: The Importance of Readability

EU MDR SSCP’s: The Importance of Readability

Among many of the new requirements that EU MDR has introduced, the Summary of Safety and Clinical Performance (SSCP) is certainly one of the more confusing ones for many firms. SSCP’s are required for implantable and Class III devices under EU MDR and is intended to be a public document summarizing important safety and clinical performance information about the device.

Avoiding Statistical Biases in Clinical Trials

Avoiding Statistical Biases in Clinical Trials

Clinical trials, when conducted with great care, are the safest and fastest way in having a treatment approved for use to improve public health1. A clinical trial is an investigation conducted under a protocol which assesses the efficacy and safety of a treatment in humans.

Investigational Device Exemption

Investigational Device Exemption

An investigational device exemption (IDE) allows for investigational devices to be used in clinical studies to collect the proper safety and effectiveness data….

Statistical Sampling

Statistical Sampling

‌  Statistics is the science of data that are used to collect a representative sample from an unknown target...

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