Clinical Trials
From Design to Report
Regulation of Clinical Trials
Clinical trials play a key role in the generation of the clinical evidence that is required for the approval of a new drug involving multiple clinical trials, different types with different objectives.
The clinical evidence generation supporting the approval of your product starts with the so called first in human study, i.e. the first administration of your drug in humans, and ends with the pivotal trial(s) confirming its efficacy and safety.
Especially for the pivotal clinical trials, it is essential that the clinical evidence requirements by the key stakeholders, drug developers, regulatory agencies, HTA (health technology assessment agencies), payers, and, finally, the patients are met and aligned.
We accompany you during the entire clinical development: planning, design, conduct, analysis, and reporting of clinical trials. With our support, you will be able to generate the clinical evidence required by the key stakeholders.
Preparation of GCP-Inspections
Before approving a new drug, regulatory agencies are often conducting GCP inspections of clinical trials. The aim of those inspections is to ensure that clinical evidence, i.e., clinical data is credible and can support the approval of the drug.
Based on our experience with GCP inspections at BfArM and in the pharmaceutical industry we provide support in its preparation, conduct, and follow-up.
Peer Review and Medical/Scientific Writing of Clinical and Regulatory Documents
We review your data and generate high-quality documents that meet your exact requirements as well as those of the regulatory agencies and other stakeholders.
EU - Clinical Trial Application and Authorisation
In the EU every clinical trial needs to be authorised by a regulatory agency and needs a favourable opinion from the ethics committee before an investigational drug can be administered to patients or healthy volunteers. In the EU, the authorisation process is regulated by the clinical trial regulation (EU 536/2014) which came into force in January 2022.
We will aid you in the planning and the preparation of all documents needed (Protocol, IB, IMPD, ICFs) for a successful clinical trial application.
US – Investigational New Drug (IND) Application
According to US current federal law a drug needs be approved before it is transported or distributed across state lines. Therefore, an IND, an exemption of above-mentioned legal condition, is required for your drug before initiating clinicals trials in the US.
We support you when preparing a submission of an IND application for your drug to the FDA.
Our services include:
- Investigator Brochures (IB) and updates
- Clinical trial protocols
- Informed Consent Forms (ICFs)
- Clinical trial registry and database summaries
- Clinical trial authorisations/Investigational New Drug (IND) applications
- Investigational Medicinal Product Dossier (IMPD)
- Briefing documents for scientific advice
- Clinical study reports (Phases I to IV)
- CTD clinical summaries and overviews
- Summary of Product Characteristics
- Patient Information Leaflets
Company Information
ConEckt Consulting, founded by Dr. med. Klaus Eckhardt, MDRA, provides expert services and advice to drug developers in academia, start-ups, global pharma and biotech industry as well as for patient organisations, investors and regulatory authorities in clinical drug development and regulatory affairs. Our focus, offering advice on evidence generation by connecting clinical insights and regulatory expertise.
Our Purpose
Expedite the provision of therapies to patients to address their unmet medical needs
Our Services
We provide independent expert services and advice in all phases of clinical drug development and regulatory affairs as well as in due diligences. We help you define innovative and robust development strategies to generate the evidence needed for your target population. We offer medical writing support when it comes to clinical documents for your marketing authorisation application.
We facilitate meetings with key stakeholders such as regulatory agencies, HTA agencies and payers support the preparation of necessary briefing packages containing a full development strategy.
Thus, we can support you throughout the entire clinical development of your projects taking care that you generate exactly the evidence that is required by key stakeholders, such as regulatory agencies, HTA, and payers.
Success of your Drug is Our Motivation – Better Treatments for Patients with Unmet Needs
* For further information see Klaus Eckhardt´s CV: Download it now!