Post Marketing Surveillance (PMS) Guide For Medical Devices

NOIDA, India - March 6, 2023 - PRLog -- What Is Post-Marketing Surveillance?

Post-marketing surveillance is the process of monitoring the safety of drugs once they arrive at the market, after the accomplishment of the clinical trials. The key purpose for accompanying post-marketing surveillance is to recognize the previously unidentified unfortunate effects as well as positive effects.

Methods of Post-Marketing Surveillance

1. Controlled Clinical Trials

Control mentions strict obedience to the protocols. The aim of which is to reduce the irregularity of many factors that might affect the results.

Limitations:

-Reports to the health authority centers directly.

-The most common traditional system in many countries

2. Spontaneous or Voluntary Recording

A communication from an independent (For example consumer, healthcare professional) to an organizational regulatory authority.

Limitations of the Spontaneous or Voluntary Recording.

-By a Communication method, from an individual to a company or a regulatory authority.

-The actual incidents of adverse drug reaction cannot be determined through spontaneous reporting.

3. Cohort, Studies

Descriptive case studies report unexpected or new events such as the incident of immediate infant death syndrome (SIDS) in numerous household siblings.

4. Case-Control Studies

The data researcher documented the survey and co-relates the circumstances observed with possible reasons.

These are neither sporadic nor cut-and-dried research. They are possibly submitted as case study reports whereby specific individual patients with differentiated clinical features are included in the study.

How Spade Health Can Help

The single most important activity that an organization must perform after its device is placed on the market is post-market surveillance. PMS activities such as data collection and analysis from multiple sources, PMCF activities, writing PMS-related reports, and updating inter-dependent regulatory documents based on PMS outcomes can overwhelm even the best teams in an organization!

Spade Health can help you in the following areas of PMS:

-Create the PMS system, including effective PMS and PMCF plans;

-Create and conduct PMCF studies;

-Collect data, analyze trends, and create PMS Reports/Periodic Safety Update Reports.

Our team includes experienced PMS Professionals, Medical Writers, Data Scientists, and Biostatisticians. We have external clinical experts on our panel who will conduct an independent review of the clinical data.

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