ICH-GCP (ICH E6 R2)

ICH-GCP defines the harmonized quality standard for clinical trials applicable in the ICH founder regions USA, Japan, EU and many other regions of the world. The ICH requirements for clinical trials are taken as a basis for clinical study quality management systems. Clinrex can help in any matter around ICH-GCP, be it training, consulting, writing/reviewing SOPs or performing quality management gap analyses. Clinrex also performs audits and mock inspections and supports you in inspection readiness. If a client needs to identify a partner in the EU, Clinrex can perform the qualification of this partner. Clinrex also offers project coordination or certain other tasks around clinical trials.

The recently introduced concept of risk-based quality management of clinical trials poses a challenge to all sponsors. What are the expectations of inspectors? How to implement the requirements into a sponsor’s/CRO’s Quality Management System?

EU Legislation for Clinical Trials: Directive 2001/20/EC and Regulation 536/2014

The EU Clinical Trials Directive aimed for the approximation of the laws and regulations in the EU Member States (MS) regarding GCP for medicinal products (drugs). By the implementation of the Directive in 2004, simplification and harmonization of the administrative provisions should have been achieved. While the Directive has succeeded in many ways, harmonization is not deemed satisfactory and duplication of work in multi-national trials contributed to the fact that an EU Regulation was developed and put in force in 2014 in order to solve these issues. However, the Regulation is not in effect yet, due to the lack of a functioning EU Portal and Database.
Clinrex can be of help with any matters related to EU Legislation on clinical trials, in particular with up-to-date trainings and the review and implementation of SOPs operating in this legal environment.

German Medicinal Product Act (AMG)

The German legislation after the implementation of the EU Clinical Trials Directive represents a challenge for everybody who wants to conduct a clinical trial in Germany. Once the EU Regulation will be in effect, Germany will face lots of changes again. Dagmar Chase's solid knowledge of the rules and regulations and good contacts deriving from over 30 years of experience in clinical trials in Germany can be of benefit for any sponsor/CRO that plans to start a clinical trial in Germany.

Review / Building of QM Systems / SOPs

External review of existing quality management systems / SOPs makes a lot of sense in order to identify procedural or regulatory weaknesses and/or unnecessary complexity which might have accumulated over the years. For start-up companies, the building of the system might be the focus. What do companies need as sponsor when starting a drug development? Or what do academic entities need when taking on the sponsor role?
Clinrex can help evaluating / (re-)writing SOPs and give advice regarding the streamlining of processes across (multinational) sponsor/CRO organizations.

Investigator Initiated Trials (IIT)

Investigator Initiated Trials are subject to the EU Clinical Trials Legislation and are explicitly supported - in the new EU Regulation through a risk-based approach and the new concept of low-interventional clinical trials. However, a lot of questions arise when an IIT is to be planned. Who will support the clinical trial in order to reach full GCP compliance? What can industry contribute without becoming the sponsor itself? What about safety data? What kind of contract must be in place?
Clinrex can help IIT sponsors to ensure GCP compliance and can help IIT supporters to handle the IIT in the right way.

Project Coordination

Supervision of complex projects and making sure that sponsor expectations are met is one of the specialties of Dagmar Chase. Clinrex can be of help for sponsors by identifying the right partners in the EU and/or globally and can offer the role of the main contact point for a sponsor. This might be of special interest for sponsors outside the EU. To make sure a clinical trial runs smoothly, i.e., the required quality standard is met and the study finishes on time and on budget, are, and always have been, the genuine goals of Dagmar Chase's work in clinical drug development.

DSMB / DMC

DSMBs / DMCs have gained importance over the last few years. One reason certainly is that the sponsor is fully responsible for a clinical trial and might have to decide on discontinuation of a clinical trial for safety or other reasons. A sponsor might be well advised to receive independent recommendations regarding critical decisions. Independent bodies need to be set up and managed. A well thought through data flow which does not jeopardise independency of the DSMB / DMC members must be established. In addition, complete documentation needs to be ensured for regulatory / GCP purposes. Dagmar Chase serves as a facilitator on a number of boards and as such represents the interface between a sponsor company and the board. This way, the sponsor is not too close to the DSMB / DMC and board independency is demonstrated.

Non-interventional Studies (NIS)

The complexity of NIS has become enormous since the new Pharmacovigilance legislation is in effect in the EU. This holds true for mono-national studies and is even to be multiplied when a NIS is planned as a multi-national project. Harmonization regarding the administrative provisions does not exist in the EU which clearly adds to the complexity. Delineation from clinical trials is a key aspect when dealing with NIS and it has to be understood that the applicable legislation for NIS differs from that for clinical trials. Dagmar Chase is the right person to provide you with an in-depth insight on NIS.

Training and Presentations

Ever since the start of her career, Dagmar Chase has been a trainer. She received an education in training skills and has held countless seminars and presentations during her professional life.