Artem Andrianov, PhD

Artem Andrianov, PhD

Frankfurt/Rhein-Main
4830 Follower:innen 500+ Kontakte

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Turning lemons into lemonade is my specialty!

Master of turning challenges into…

Artikel von Artem Andrianov, PhD

Beiträge

Aktivitäten

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Berufserfahrung

Ausbildung

  • Bayes Business School Grafik

    Bayes Business School

    Activities and Societies: M&A, New venture creation, London Squash club, ERT MBA group

    Graduated with Honors in Finance, Quantitative Methods, Mergers and Acquisitions, etc. Focused on Finance, Corporate Strategy and New Product Development. During the study successfully fulfilled research projects for GlaxoSmithKline (GSK), Johnson & Johnson, ERT.

Bescheinigungen und Zertifikate

Veröffentlichungen

  • Adoption of RBQM in Academic Settings: Lessons Learned

    Applied Clinical Trials

  • The PUEKS Project: Process Innovation in Clinical Trial Monitoring

    Applied Clinical Trials Journal

    The PUEKS Project (Process Innovation in Clinical Trial Monitoring) complements other cross-stakeholder collaborations such as the Clinical Trial Transformation Initiative (CTTI), TransCelerate Biopharma Inc., and the Metrics Champions Consortium (MCC) to innovate and improve clinical trial quality management.

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  • ICH GCP Goes Risk Based

    Applied Clinical Trials

    The new upcoming GCP E6 (R2) addendum has the potential to reform clinical monitoring and clinical trial management. What changes does it bring to all of us? What does this mean for a pharmaceutical company, for a Contract Research Organization (CRO) and for an investigator in terms of changes to the processes of trial oversight, data collection and reporting and trial design and planning? In this article, you will find a structured summary and critical review of the new addendum, and as well…

    The new upcoming GCP E6 (R2) addendum has the potential to reform clinical monitoring and clinical trial management. What changes does it bring to all of us? What does this mean for a pharmaceutical company, for a Contract Research Organization (CRO) and for an investigator in terms of changes to the processes of trial oversight, data collection and reporting and trial design and planning? In this article, you will find a structured summary and critical review of the new addendum, and as well as ideas on how to prepare for these regulatory changes.

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  • GCP Change – New Risks for Biotech?

    Going Public Biotechnology

    The new upcoming GCP E6(R2) addendum reforms clinical monitoring and clinical trial management. Risk factors are an important component. What this means for a biotech company: clinical trial risks are easy to foresee, site level risks and operational risks are hard to detect; in this article, you will find a step by step approach to how to turn the new regulation to your best advantage.

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  • Quality Risk Management as a Survival Kit: From Idea to Implementation

    DIA Global Forum

    Efficient risk management becomes a survival kit for a modern pharmaceutical company. How should one select from the available Risk-based Monitoring (RBM) solutions? This article explains the main principles of Risk-based Monitoring, refers to the changing regulatory environment (GCP addendum E6-R2) and categorizes available RBM technologies by IT infrastructure, data sourcing, assessment frequency, risk areas and feature-sets. Moreover, it provides a simple to follow framework for RBM…

    Efficient risk management becomes a survival kit for a modern pharmaceutical company. How should one select from the available Risk-based Monitoring (RBM) solutions? This article explains the main principles of Risk-based Monitoring, refers to the changing regulatory environment (GCP addendum E6-R2) and categorizes available RBM technologies by IT infrastructure, data sourcing, assessment frequency, risk areas and feature-sets. Moreover, it provides a simple to follow framework for RBM technology selection and a systematic five-step RBM rollout consisting of: proof concept, pilot project, lessons learned, adjustment of RBM and final rollout.

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  • How Do We Define Clinical Trial Data Quality if No Guidelines Exist?

    Applied Clinical Trials

    Many of us speak about the importance of clinical trial data quality and integrity, yet the lack of data quality standards and definitions introduces subjectivity risk in clinical trials.

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  • Avoide Potential Pitfalls around RBM

    Applied Clinical Trials, Risk-Based Monitoring E-Book

    When implementing RBM, make sure patient safety and data quality are still at the forefront.

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  • Can RBM Influence the Data Quality and Patient Safety Inversely?

    Applied Clinicaltrials Online

    “Never assume that something obvious is true,” a good friend of mine told me—a researcher with 20 years of experience, and one of the wisest men I have met in my life. Many years later, this advice would guide me to critically consider and analyze Risk-based Monitoring (RbM).

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  • RbM Guidance Document: Ten Burning Questions about Risk-Based Study Management

    Applied Clinical Trials Online

    The RbM Consortium is a transnational alliance of quality risk management industry experts, risk-based technology firms, data analysts, and biopharmaceutical business strategists. Members of this group include WSQMS, PPH plus, Cyntegrity, and Annex Clinical. The objective of this collaboration is to improve awareness of Risk-based Monitoring (RbM) in clinical trials, to advise biopharmaceutical enterprises, medical device companies, CROs, study sponsors, and study sites on best practices, and…

    The RbM Consortium is a transnational alliance of quality risk management industry experts, risk-based technology firms, data analysts, and biopharmaceutical business strategists. Members of this group include WSQMS, PPH plus, Cyntegrity, and Annex Clinical. The objective of this collaboration is to improve awareness of Risk-based Monitoring (RbM) in clinical trials, to advise biopharmaceutical enterprises, medical device companies, CROs, study sponsors, and study sites on best practices, and communicating the best implementation strategies on sound quality risk management systems, technologies, and business methodologies in RbM. This guidance document offers information about RbM strategies.

    Andere Autor:innen
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  • RbM Guidance Document: Ten Burning Questions about Risk-Based Study Management

    Applied Clinical Trials Online

    The RbM Consortium is a transnational alliance of quality risk management industry experts, risk-based technology firms, data analysts, and biopharmaceutical business strategists. Members of this group include WSQMS, PPH plus, Cyntegrity, and Annex Clinical. The objective of this collaboration is to improve awareness of Risk-based Monitoring (RbM) in clinical trials, to advise biopharmaceutical enterprises, medical device companies, CROs, study sponsors, and study sites on best practices, and…

    The RbM Consortium is a transnational alliance of quality risk management industry experts, risk-based technology firms, data analysts, and biopharmaceutical business strategists. Members of this group include WSQMS, PPH plus, Cyntegrity, and Annex Clinical. The objective of this collaboration is to improve awareness of Risk-based Monitoring (RbM) in clinical trials, to advise biopharmaceutical enterprises, medical device companies, CROs, study sponsors, and study sites on best practices, and communicating the best implementation strategies on sound quality risk management systems, technologies, and business methodologies in RbM. This guidance document offers information about RbM strategies.

    Andere Autor:innen
    Veröffentlichung anzeigen
  • Case Study: Using RBM to Evaluate and Predict Site Engagement

    Applied Clinical Trials

    Clinical trial site engagement has been advocated as a critical component relating to a study’s performance and success, however, a minimum amount of data supports this connection. Researchers have acknowledged that medical engagement correlates with performance and innovation, nonetheless, direct causality is unclear...

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Auszeichnungen/Preise

  • MCC Champion

    Metric Champion Consortium

    "I am pleased to share the exciting news that you have been selected as a member of this year's group of MCC Champions - a special honor bestowed upon individuals who made significant contributions in 2016 to advancing the MCC mission to improve the efficiency, quality and effectiveness of clinical trials. Congratulations!"

    Linda B. Sullivan
    Co-Founder & President

  • German Leadership Program

    Cognos; InWEnt Capacity Building International

    International internship in Germany, the initiative for educating prospective industry leaders

Sprachen

  • German

    Verhandlungssicher

  • English

    Verhandlungssicher

  • Latin

    Grundkenntnisse

Organisationen

  • DGGF

    member

    –Heute
  • DGPharMed

    -

    –Heute
  • RBM Consortium

    Member

    –Heute
  • DIA

    -

    –Heute

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