We are aware that every company has different needs and every system has different risks. Therefore, we listen, assess the gaps, evaluate the risks, and offer manageable
solutions tailored to your company.

Electronic Solutions Strategy and Concepts

We are living in a digital world in which electronic solutions are an essential part of clinical trials. Some systems like Electronic Case Report Forms (eCRFs), Pharmacovigilance Systems, Clinical Trial Management Systems (CTMS), and Interactive Web Response Systems (IWRS) are well established. Electronic Trial Master Files (eTMF) and Electronic Patient Record Outcomes (ePRO) are slowly replacing paper TMF and diaries. Some systems are hardly used, e.g. electronic informed consent or artificial intelligence.

  • What kind of systems do make sense in your study and organization?
  • How much integration makes sense?
  • What do you have to consider?
  • What about cloud systems?

We can help you with these questions.

Computer System Validation

Computer System Validation in Clinical Trials has become more into focus since 2016 which has been in ICH E6 (R2) and was stressed in April 2020 by the European Medicines Agency in the «Notice to sponsors on validation and qualification of computerised systems used in clinical trials.»

With more than 15 years of experience in computer system validation projects we can support you to ensure the quality and the validation of your systems. We look for pragmatic solutions based on the risks to the «intended use of the system and the potential of the system to affect human subject protection and reliability of trial results.» ICH E6 (R2).

Quality Management Systems

Quality Management Systems (QMS) are not fixed but ever evolving systems. It is important to ensure that your QMS evolve in a way that it fits well to your organization. It is as unique as you. After seeing many different solutions in hundreds of audits and assessments we can support you with enhancing your quality system depending on the size and organization of your company and your specific needs either as part of a quality project, implementation of CAPAs, or as consulting on a specific question.

Data Privacy

International data privacy regulations have an impact on clinical trials. Data of patients, investigators, and employees are stored and processed in many different countries and has to be protected. What has to be considered in clinical trials? Ask us.