Clinical Services
Our aim is to provide high-quality advice tailored to your product on its way to approval by connecting the necessities of clinical development with the regulatory requirements.
You will benefit from our expertise and experience as we link our clinical insights in particular into multiple indications in neurology (epilepsy, pain), immunology (rheumatoid arthritis, psoriasis), and target populations with our knowledge of regulatory environment (link to our expertise and experience under about).
It is essential to generate the appropriate clinical evidence for your product to support a successful application for its approval.
We will help you to identify the key clinical benefits and key clinical risks to obtain a positive benefit-risk assessment for your project.
With us, you will be able to plan and establish an optimal clinical development.
We offer advice on the design of the key clinical trials from first-in-human trials to dose-finding trials, to large pivotal trials with the goal of a successful authorisation of your product.
Together, we develop an optimized overall strategy aligning clinical development with regulatory requirements in agreement with the respective agencies.
What we offer:
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!