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LifeSphere IDMP Compliance

The IDMP groundwork provides pharma companies with the convenience to improve necessary data processes across the regulatory lifecycle, which will also significantly impact regulatory affairs, operations, pharmacovigilance, data management and more.

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What is IDMP?

Identification of Medicinal Products(IDMP)refers to a framework of five standards developed by the International Organization for Standardization (ISO) to uniquely identify medicinal products, standardize product information, and facilitate smooth exchanges between pharmaceutical companies and global regulators to improve patient safety.

IDMP standards require pharmaceutical and life science organizations to electronically submit and maintain detailed product data for all products marketed in Europe.

What Are The Five Standards?

  1. Medicinal Product Identification (MPID)
  2. ISO 11615: This standard defines the data elements and identification structure of regulated medical products intended for human use.

  3. Pharmaceutical Product Identifier (PhPID
  4. ISO 11616: This standard outlines the data and structure to uniquely identify a generic pharmaceutical product at various elemental stages.

  5. Substance Identification (SubID)
  6. ISO 11238: Refers to the general, main, and specified characteristics used to define a substance as a medicinal product.

  7. Dosage Form and Route of Administration
  8. ISO 11239: Outlines the standards for structuring and exchanging pharmaceutical dose forms, packaging, and facilitating routes of administration.

  9. Units of Measurement (UoM)
  10. ISO 11240: This standard defines rules for the usage of measurement units, including guidelines for language translations and international metrological measurement standards.

Ready for Future Growth

As a hosted solution on our secure validated cloud, LifeSphere IDMP adapts over time to support your journey through continued xEVMPD compliance, multiple phases of IDMP compliance, UDI and beyond

Simplifying IDMP Compliance

LifeSphere IDMP simplifies the compliance process by delivering a single source of truth for all medicinal product information in IDMP, xEVMPD, and other formats, and it comes with built-in business validation rules.

Innovative Automation

LifeSphere IDMP seamlessly curates, manages, and drives submission data alongside Lifesphere RIMS or alongside your RIMS system. Advanced AI-driven automation creates an agile foundation, allowing teams to quickly adapt to new regulatory requirements.

Is There a Timeline for IDMP Compliance?

According to the EMA (European Medicines Agency), they will be the first major health agency to mandate IDMP compliance, with the FDA (U.S. Food and Drug Administration) expected to make the mandate as well.

Pharma companies and organizations face a rapidly shortening window to prepare for this full transition of regulatory data and regulatory systems to adhere to with this complex IDMP compliance mandate.

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What Are Some Common Benefits of LifeSphere IDMP?

With LifeSphere IDMP, you will be able to easily improve efficiency, productivity and cost savings.

Below are some of our benefits of our IDMP:

Seamless Integration with Existing Systems: The open architecture of LifeSphere IDMP makes it easy to link source systems with IDMP data.

Simple, Easy-to-Learn Interface: Designed to be easy and intuitive to use, with an interface designed for users of all skill levels.

Pre-Validated Cloud UpdatesLifeSphere IDMP provides seamless, pre-validated cloud updates to the latest functionality, insulating companies from changing requirements and avoiding disruption to their validated environment.

Worry-Free Implementation: Fast, knowledgeable teams adhere to industry best practices to get up and running quickly.

No Extensive Training Required: Designed to be easy and intuitive to use, with an interface designed for users of all skill levels.

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An Easy and Intuitive CTMS for Organizations of All Sizes

LifeSphere CTMS10 is a core offering in LifeSphere Clinical’s unified cloud platform.

LifeSphere CTMS10 is an end-to-end solution that makes the entire clinical trial management process easier and more transparent for companies of all sizes.

The Evolving Role of CTMS in Risk Management

Clinical trials are a necessary and critical activity in releasing new, and often-times lifesaving, drugs and medical devices to the market. To achieve success, however, in the face of rising development costs and fewer approvals, life sciences organizations are under severe pressure to manage these trials in a way that is risk-averse and cost-effective.

The Benefits of a Unified Clinical Platform

For nearly 20 years the issue of disconnected, poorly integrated systems and processes has hampered clinical R&D. The problem and its challenges have been discussed, dissected, and top of mind of most clinical operations leaders. The constant and critical push to accelerate a product’s time to market continues to push clinical teams to seek solutions that deliver greater efficiencies. After 20 years of point-to-point integrations, the time has come for a different, advanced, and unified approach.

The Clinical Domain is Evolving. Make Sure Your CTMS is Evolving With It

The Evolving Role of CTMS in Risk Management takes a broad look at the challenges facing clinical trial management, how the clinical domain is changing, and how the industry can better respond.

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