Our support for your success
Investigator Initiated Trials (IITs) are an essential part of clinical research that are initiated and conducted by a researcher or research group. These studies offer a unique opportunity to investigate scientific questions independently of commercial interests, contribute significantly to medical innovation and can sustainably improve patient care.
We offer comprehensive support in the planning and implementation of your IITs so that you can concentrate on the essentials: Research. Our experienced team is with you every step of the way, from the development of customized study protocols to submission to the relevant authorities. We ensure that your study meets the highest quality and compliance standards.
Our competencies for Investigator Initiated Trials include:
Study planning and design: We support the development of customized study protocols that are tailored to the specific research questions and objectives of the Investigator Initiated Trials. This includes feasibility studies, the selection of suitable endpoints and biomarkers as well as the implementation of case number calculations.
Regulatory Affairs: Our team advises and navigates you comprehensively through the complex regulatory requirements and supports you in the preparation and submission of the necessary applications. Our close cooperation with the relevant authorities ensures that your study meets all legal requirements and that you can concentrate on your research. To this end, we take care of communication with authorities and ethics committees and, if necessary, accompany audits and inspections.
Project management: Efficient coordination of all departments involved is crucial for the success of Investigator Initiated Trials. From developing a customized study protocol to conducting feasibility studies, we ensure that your study is implemented efficiently and within budget by acting as a single point of contact and seamlessly integrating all disciplines. Our experts coordinate all disciplines and ensure that your research runs smoothly.
Site management: The selection and qualification of suitable test sites is a critical factor for the smooth running of the study. We take care of contract and budget negotiations and provide training and ongoing support for the trial staff.
Clinical monitoring: To ensure the quality, integrity and safety of the study, we offer a wide range of monitoring services, including on-site, remote and centralized monitoring as well as risk-based monitoring.
Clinical data management: We use validated eCRF systems and ensure data quality assurance and GDPR-compliant data management.
Procedure of an Investigator Initiated Trial:
Running an Investigator Initiated Trial (IIT) is a structured process that requires careful planning and coordination to meet both scientific and regulatory requirements. Here is a detailed overview of the steps involved in conducting an IIT:
Concept development: The first step is to formulate a clear research question and develop a concept for the study. This includes defining the study objectives, selecting the target population and determining the methodology. A preliminary budget is also drawn up at this stage to determine the financial requirements of the study.
Preparation of a study plan: A detailed protocol is created to guide the conduct of the study. This plan covers all aspects of the study, including study design, timing, data management and statistical analysis. The protocol forms the basis for submission to ethics committees and authorities and must comply with Good Clinical Practice (GCP) guidelines.
Submission to the competent authorities: Approvals must be obtained from the ethics committee and, if necessary, from higher federal authorities before the study begins.
Conduct of the study: Careful monitoring is required during the conduct of the study to ensure the integrity of the data and the safety of the participants. This includes regular reviews and, if necessary, adjustments to the study protocol and compliance with quality standards.
Evaluation of the data: Once data collection is complete, a comprehensive analysis is carried out to answer the research questions and document the results. This phase includes the preparation of final reports and, if necessary, the publication of the results in scientific journals.
Responsibility:
The initiator of an IIT bears overall responsibility for project management and study implementation. This includes compliance with regulatory requirements, the preparation of study protocols and final reports, and study monitoring.
Regulatory requirements:
IITs are subject to the same strict regulatory requirements as commercial clinical trials. They are conducted in accordance with Good Clinical Practice (GCP) guidelines and legal requirements for medicinal products, such as the EU CTR (Regulation 536/2014) and the German Medicines Act (AMG), or for medical devices, such as the Medical Device Regulation (Regulation 2017/745) and the German Medical Devices Act (MPDG) in conjunction with ISO 14155. Before the study begins, the necessary approvals must be obtained from the ethics committee and, if applicable, from the higher federal authorities.
Support from our team
Our experienced team will support you every step of the way, ensuring that your study meets the highest quality and compliance standards. We offer support in all areas, from concept development to data analysis, ensuring your IIT is conducted efficiently and successfully. Contact us for a free consultation and learn more about our Investigator Initiated Trials services. Together, we can realize your research ideas and make a significant contribution to improving patient care.
Locations
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contact@mediconomics.com
+49 (0) 511 560 998-0
Call us
And what can we do for you?
Dr. (MD) Uwe Albrecht,
FIBMS, FFPM (Dis.), FICR, CSci
CEO
Headquarters
Hanover
FAQ – frequently asked questions
As an experienced CRO, Mediconomics offers tailored support for your specific research. We help you efficiently meet regulatory requirements, optimize study quality, and make optimal use of resources.
We advise you on creating realistic budgets and help you make optimal use of funding. Our cost-effective solutions are specifically tailored to academic research projects.
We tailor our services precisely to your needs – from one-off consultations to comprehensive study support. You decide in which areas you need support.