EmMA is your AI-powered assistant for navigating TMF regulations, EMA guidelines, and inspection findings.

About EmMA

EmMA - Regulatory AI Assistant
Your AI TMF Regulations Assistant
What can EmMA help you with?
  • Data direct from the EMA
  • TMF Regulations and Guidelines
  • CSV Guidelines
  • Recent Q&As
  • Common inspection findings
"Ask me about TMF compliance"

Meet EmMA

EmMA is an AI-powered regulatory assistant designed to help you with TMF regulations, guidelines, and EMA inspection findings.

Let's take a look at how EmMA was built and how she can help you.

How was EmMA created?

We started by collecting and studying key regulatory documents from the European Medicines Agency (EMA):

We then extracted the text from these documents, split the content into manageable sections ("chunks"), and generated vector embeddings for each chunk. These embeddings allow EmMA to efficiently search and retrieve relevant information in response to your questions.

How does EmMA answer your questions?

When you type a question in the chat window, EmMA searches through information from official documents. She finds the most relevant pieces, and then the AI uses both its pre-trained knowledge and the retrieved information to write a helpful answer for you. This way, you get answers that are based on real, trusted sources.

Technical Details: Retrieval-Augmented Generation (RAG)

EmMA uses a technique called Retrieval-Augmented Generation (RAG) to answer your questions. Here's how it works under the hood:

  • Vector Embeddings: Each section ("chunk") of the regulatory documents is converted into a mathematical representation called an embedding. This allows EmMA to compare the meaning of your question with the content of the documents.
  • Similarity Search: When you ask a question, EmMA transforms your query into an embedding and searches for the most similar chunks in its database using fast similarity search algorithms.
  • Generative AI: The most relevant chunks are then provided as context to a large language model (LLM), which generates a clear, helpful answer based on both your question, the retrieved information, and its own pre-trained knowledge.

This approach ensures that answers are not only accurate and relevant, but also grounded in the latest regulatory guidance and best practices.

What kinds of questions does EmMA excel at?

EmMA is especially helpful for questions like:

  • "What are the essential documents for TMF compliance?"
  • "How should I prepare for an EMA inspection?"
  • "What are the requirements for electronic signatures in clinical trials?"
  • "What are common inspection findings?"

Currently, EmMA is designed to answer single, focused questions. For complex or highly specific regulatory matters, always consult the original documents or a qualified regulatory expert.