Welcome
The Subject Matter Expert. Be sure you are compliant. GXP Compliance.
Compliance, Quality, Efficiency. Be sure you are compliant.
About Us
Our Mission
Founded in 2011 by Kamila A. Novak, MSc, KAN Consulting provides auditing, consulting, medical writing services, and training courses to biotechnology and pharmaceutical companies and CROs as well as institutions and individual researchers – investigators to ensure compliance in the complex regulated drug and device development landscape.
Our goal is to support your business objectives and, ultimately, help patients to benefit from new therapies as soon as possible.
Your Consultant
Kamila A. Novak holds a master’s degree in molecular genetics. She has been involved in clinical research since 1995, having worked in various positions in pharma and CROs. Since 2010, she has been working as an independent consultant.
Her business activities include medical writing, auditing, quality management risk management system implementation, and training.
Kamila Novak is a certified Lead Auditor for ISO 9001:2015 and ISO 31000:2018, Certified ISO 14155:2020 Medical Devices auditor, and cGMP – QMS auditor. She is a member of the Society of Quality Assurance (SQA), the Association for GXP Excellence (AGXPE), the Drug Information Association (DIA), the European Medical Writers’ Association (EMWA), the Continuing Professional Development (CPD) UK, and other professional societies.
In the DIA, Kamila Novak serves as a Co-Chair of the Clinical Research Community, a Core Team Member of the GCP & QA Community, leads Working Groups on Computer System Validation and on Data Interoperability, and is a member of Working Groups on Clinically Meaningful Outcomes, and Project Management.
Clients' Benefits
Everyone could do with a bit of extra time and money and KAN Consulting can help save you both. Whether you are a biotechnology or pharmaceutical company, an institution representative, an investigator, or a CRO, you may find something in our offer you can benefit from.
Institutions
Institutions engaged in research, whether conducting its own or industry-sponsored projects, are more successful with functional research offices or centres taking care of organisational and technical aspects of studies. It relieves investigators and their teams from the administrative burden allowing them to focus on the science and patient care. KAN Consulting supports institutions wishing to enhance their research potential with
- Establishment or optimisation of research office operations,
- Training of personnel, including but not limited to GCP, regulations, study management for investigational sites, contract negotiation, protocol development.
Investigators
Whether you are just starting your research career or run your own studies routinely, a strong project plan including budget calculations will help you to present your research idea to the grant committee or find a sponsor in the industry. Pharmaceutical and biotechnology companies do offer funding, however, each investigator-driven project undergoes a thorough scrutiny in order to get selected for funding.
KAN Consulting offers support in
- Project plan development and its presentation to increase your winning score.
- Protocol development.
- Study report and manuscript writing.
Sponsors and CROs
Our industry clients are particularly interested in
- Specialised training courses and workshops on project management, risk management, negotiation skills, presentation skills and business development;
- Support in implementing advanced project management and risk management approaches to keep pace in the rapidly changing drug development environment.