ARTICLES BY KAMILA NOVAK

  • A Firsthand Experience In Africa — Sub-Sahara Has A Lot To Offer
    12/6/2022

    In “Better Than Expected — A Firsthand Experience In Africa,” Kamila Novak shared her positive impressions from visiting medical research centers in sub-Saharan Africa. However, the picture would not be complete without talking about the continent’s personal safety and professional security, regulatory landscape, and ongoing socioeconomic challenges.

  • Should We Pay Patients In Clinical Trials For Their Time?
    9/29/2022

    Many countries don't reimburse clinical trial patients for their time and inconvenience. Is it ethical to pay them or not? This article looks at the perspectives of some of the major regulatory authorities. Can we find common ground? What actions can we take as members of industry?

  • A 4-Step Strategy For Small Sponsors To Select The Right CRO
    8/31/2022

    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?
    1/25/2022

    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.

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.