Flexible solutions. Your success.

Trusting staff to work flexibly is key in the talent stakes

With more than 90% of Millennials saying flexible working is important to them, firms that don’t trust their staff to do so responsibly risk alienating and deterring talent.









A Roadmap for Implementing Risk-Based Monitoring and Quality Management


Are you implementing or preparing to implement RBM and risk-based quality management approaches? Johann Prove presented at 2018 DIA a roadmap beginning with a look at pre-study risk planning, vendor selection and change management in RBM and RBQM.

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Risk-Based Monitoring as Best Practice

Centre Watch has published a recent survey which proposed RBM a “best practice” because indicates:

  • A 16 percent reduction in critical and major findings in site audits;
  • Seventeen percent better detection of significant deviations; and
  • Forty-five percent fewer missing pages in RBM trials versus trials using traditional monitoring methods.
  • Costs savings of up to 15 percent











For further information:

Risk-Based Monitoring Should Be Best Practice, ACRO Tells FDA

New ICH E8 General Trial Design and Conduct

The modernized revision adds a new section on designing quality into clinical studies that focuses on the need to identify a basic set of “critical-to-quality” factors that the guideline defines as “attributes of a study whose integrity is fundamental to the protection of study subjects, the reliability and interpretability of the study results and the decisions made based on the study results.” Those factors should be adaptable to a variety of trial designs, the guideline says.

The new document also emphasizes the importance of patient centricity in trial development. “Involving patients at the early stage of study design is likely to increase trust in the study, facilitate recruitment and promote adherence, which should continue throughout the duration of the study,” the guideline says.

ICH is seeking comments on the draft by October and plans to release the final CIHE8 (R1) by June 2020.

ICH Releases Draft Revision of Guideline on General Trial Design and Conduct

Towards a new regulation of observational studies with medicines in Spain

The future Royal Decree will be applicable to all observational studies with medicinal products for human use defined in Royal Decree 1090/2015, of December 4, which regulates clinical trials with medicines, Research Ethics Committees with medications and the Spanish Registry of Clinical Studies, and that are carried out in Spain.

As new features to be highlighted is the use of a nomenclature closer to the reality of the field of research whose examples are:

  • definitions of the beginning or end of the study, pseudonymization, substantial modification of the protocol, protocol;
  • the application of the definitions provided for in article 2 of Royal Decree 1090/2015 – among which are the definition of adverse reaction, usual clinical practice, promoter, principal investigator or informed consent – and
  • definitions regarding the Post-authorization security studies and the risk management plan included in Royal Decree 577/2013 regulating the pharmacovigilance of medicines for human use.