• A 4-Step Strategy For Small Sponsors To Select The Right CRO

    Selecting the right CRO to conduct our clinical study is not a difficult task, right? It's a bit more complicated than choosing a one-stop shop. You need to ask yourself questions such as: "What are our needs and requirements?", "How many providers and vendors do we want to engage?", and more.

  • Should We Build Or Break Skill Silos In Clinical Trials?

    We tend to forget to talk about the knowledge and skill silos in clinical trials that we have built over the years. This article describes how the industry got to where we are with narrow specialization and recommends 5 strategies to break skill silos.

  • Data Interoperability: The First Step To Leverage ML & AI In Clinical Trials

    The first hurdle we need to overcome to leverage machine learning and AI in clinical development is data interoperability. We must break data silos, find a way to make the data points communicate with one another within the drug development continuum, and analyze each data point in its full context. This article also delves into the importance of metadata and the differences between different data formats.

  • Best Practices for Risk Assessment of GxP Vendors and Inspection Readiness

    Requirements for risk management in clinical trials are outlined in GCP (R2) and provide you, as the sponsor, with the main steps for risk management in your studies. The implementation will vary from vendor to vendor depending on their delegated duties and functions. In addition to that, there are three other important considerations.

  • What Risk-Based Oversight Of GxP Vendors Is & Is Not In Clinical Trials

    Some pharmaceutical companies still have a notion that delegating responsibility for a clinical trial to a vendor is a way to transfer risks related to the delegated duties and functions. Nothing is further from the truth. This article examines what is vendor oversight in the context of ICH's GCP (R2) guideline.

Kamila Novak

Kamila Novak

Kamila Novak, MSc, got her degree in molecular genetics. Since 1995, she has been involved in clinical research in various positions in pharma and CROs. Since 2010, she has been working as an independent consultant focusing on QA and QC, as a certified auditor for several ISO standards, risk management, medical writing, and training. She is a member of the Society of Quality Assurance (SQA), the World Medical Device Organisation (WMDO), the European Medical Writers’ Association (EMWA), the Drug Information Association (DIA), the Continuing Professional Development (CPD) UK, and other professional societies.