Clinical Research (ClinRes)/
Trial Management at the IFS


Trial Management

The IFS provides the consulting and support necessary to design, conduct, and evaluate clinical trials. We manage trials in many different indications in accordance with the German Medicines Act AMG) and the German Act on Medical Devices (MPG), as well as studies beyond the area of these regulations, for example, psychotherapeutic and diagnostic trials. Our trial management services can be tailored to suit each study.

Our team provides these consulting services to the departments of the Universitätsmedizin Göttingen (UMG) as well as to external institutes and pharmaceutical companies.

This consulting service includes organizational, regulatory, methodological, and financial issues such as:

  • Reviewing the concept of a proposed project
  • Ascertaining feasibility
  • Advising during preparations for trials
  • Assessing the project’s compliance with regulatory provisions
  • Developing procedures to meet special regulatory demands
  • Supporting design and risk analysis efforts
  • Drafting efficient protocols
  • Supporting efforts to conclude and evaluate trials


Further Clinical Research/Trial Management services:

The project manager is the key point of contact for services performed by the IFS. Project managers provide advice during the designing phase, coordinate clinical trials to include cooperating with research facilities and institutes, manage the training of personnel involved in the study, and draft funding proposals. Our project managers deliver qualified professional services and cooperate closely with customers.

Our Project Management services include:

  • Budgeting for clinical trials
  • Reviewing national and international regulatory requirements
  • Providing medical writing services
  • Procuring insurance for trial subjects/ and patients
  • Communicating and coordinating with authorities and commissions
  • Liaising with sponsors, principal, investigators, administrative offices, funding agencies, and other partners
  • Monitoring trial milestones
  • Reporting on the status of clinical trials
  • Organizing and coordinating meetings and telephone conferences


Regulatory Affairs staff are tasked mainly to coordinate among authorities, pharmaceutical companies, and investigators, and to ensure compliance with the statutory provisions currently in force.

Specifically, this entails:

  • Registering clinical trials and obtaining approvals to conduct these studies
  • Ensuring applications are submitted on time to the appropriate ethics committee and state and federal authorities (BfArM, PEI)
  • Helping investigators comply with applicable regulations and laws (AMG, GCP V, MPG, the EN ISO Standard 14155 1/2, among others), and design and conduct national and international clinical studies
  • Cooperating with the pharmaceuticals industry, research institutes, and the diverse specialized departments of clinics to create the documents necessary to obtain approvals for drugs and medical devices

The IFS' monitors are responsible for quality control at the investigative sites. Monitoring is mandatory for clinical trials to ensure they are conducted in accordance with GCP. It is also indispensable to generating credible data. In the interests of effective monitoring, the IFS monitors strive to cooperate closely with the investigators.

The monitor operates on site at the investigative facilities and liaises between the sponsor and the investigators. Our monitors have earned university science degrees and completed IFS' internal training as well as courses conducted by external organizations.

Monitoring services include:

  • Initiating investigative sites
  • Performing full or random-sample source data verifications
  • Auditing documentation and case report forms
  • Monitoring the protocol and ensuring legal compliance
  • Providing trial documents and investigational medicinal products
  • Reporting on the status of clinical trials

The IFS offers advice and assistance to investigators seeking to design the biometrics and to analyze the statistics of clinical trials.

Specifically, this includes:

  • Offering guidance on selecting a suitable clinical trial design and outcome criteria, as well as determining statistical methods
  • Calculating the sample size and randomizing patients according to the chosen method and design
  • Creating the biometrics section of the protocol
  • Providing statistics-related services such as drafting a statistical analysis plan (SAP), performing interim and final analyses, and authoring the biometrical report
  • Performing statistical analyses according to ICH-GCP and using SAS® statistics software

Our Data Management unit is the information hub for investigators, biometrics experts, and monitors, whereby interdisciplinary cooperation with further departments of the IFS such as Clinical Trial Management and Study Nursing figures prominently. The rules set out by national and international standards (ICH-GCP) as well as our standard operating procedures (SOPs) govern our data management practices.

Our Data Management services include:

  • Creating eCRFs using secuTrial®, a 21CFR Part 11-compliant electronic data capture systems (EDC), in cooperation with the Medical Informatics department of Universitätsmedizin Göttingen (UMG)
  • Training investigators and monitors
  • Performing systematic data and plausibility checks as well as patient data integrity checks using SAS® statistics software



To learn more about Clinical Research/Trial Management at the IFS, please contact:

Dr. Heike Hennig – Head of Clinical Research
Phone: ++49 (0) 551 - 39 - 172249
Fax: ++49 (0) 551 - 39 - 171344
E-Mail: hennig.ifs@med.uni-goettingen.de

Dr. Andreas Molitor – Head of Clinical Trial Management
Phone: ++49 (0) 551 - 39 - 175645
Fax: ++49 (0) 551 - 39 - 171344
E-Mail: molitor.ifs@med.uni-goettingen.de