About us

We are an academically focused clinical research institution and full service CRO affiliated with Northwest Hospital and University Cancer Center (UCT) Frankfurt/Germany. Focused on cutting-edge, investigator-initiated cancer research, we provide clinical researchers as well as biotech and start-up companies with a high-end, completely scalable (from full-service to tailor-made selection of tasks), independent, and professional platform for planning and conduct of scientifically motivated clinical research. Our mission is to advance scientifically motivated clinical research on cancer and help delivering answers to current and future important clinical questions in this field.

20+

Years of
Experience

5K+

Patients
in Trials

300+

Clinical
Centers

Research

Clinical Research

Excellence In Research

The objective for our research activities is clearly set: Facilitate excellent clinical cancer research at international level to improve the treatment and quality of life of patients suffering from cancer.We are not a pharmaceutical company and therefore our real ‘product’ is the gain in scientific knowledge. This is achieved by clinical trials that focus on endpoints relevant to patients such as response rate, survival and quality of life.

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Translational Research

Translational research is an important component of our study designs. Wherever possible, we collect materials to help researchers gaining a better understanding of pathogenesis and development of cancer. Currently, we are participating in several projects and work with TR initiatives like the German Cancer Consortium (DKTK).

Precision Oncology

We help our academic partners improving personalized cancer therapy by establishing large networks for molecular profiling. IKF is the home of several networks including:

- PLATON (Platform for Analyzing Targetable Tumor Mutations) for Gastrointestinal Cancer

- PARAGON: Platform for Outcome, Quality of Life and Translational Research on Pancreatic Cancer

- GISAR: German Sarcoma Registry

Clinical Research

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Excellence in Research

The objective for our research activities is clearly set: Facilitate excellent clinical cancer research at international level to improve the treatment and quality of life of patients suffering from cancer. We are not a pharmaceutical company and therefore the ‘product’ we offer is the gain in scientific knowledge. This is achieved by clinical trials that focus on endpoints relevant to patients such as response rate, survival and quality of life. Our mission is to design and successfully conduct such studies in close cooperation with our scientific partners. In our work, we emphasize clinical relevance and provide answers to long-standing clinical questions to make sure our studies provide improvements to the everyday life of patients.

IITs

To accomplish this, we rely on our extensive and long-standing experience in the field of investigator-initiated trials (IITs), which have been and always will be a focus of our work. Therefore, IKF Klinische Krebsforschung GmbH is often the sponsor of phase I to phase III IITs with internal or external lead investigators who are among the best experts in their fields, worldwide. Some of our studies have changed standards of care around the globe, e.g. for patients suffering from stomach or esophageal cancer. A fact which we remain to be very proud of.

Early Clinical Research

Within the last decades, we accumulated profound expertise in designing and conducting early clinical trials, including first in man studies, specifically on immunotherapeutic agents and targeted therapies. For the conduct of early clinical trials, we partner public research institutes or excellent start-up biotech companies who proved to have promising compounds and mutually develop their drugs until approval or successful out-licensing.

Services

Full-Service CRO

High end completely scalable platform from full-service to tailor-made selection of tasks (e.g. project design and development, preparation of clinical trial protocols…

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Datamanagement

Our data management focuses on quality control and data integrity of the clinical study database - from database setup to database lock ...

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Statistics

Statistical parameters play an important role to ensure the overall success of a clinical trial. Our statistics team is therefore already involved in the planning of the study ...

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We are unique because

We have multidisciplinary teams, We have excellent networks ...

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Full-Service CRO

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Datamanagement

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Statistics

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We are unique because

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We are a high-end completely scalable platform from full-service to tailor-made selection of tasks. These tasks include:

  • Study related processes in accordance with AMG (German medicines act) and ICH-GCP
  • Project design and development including complex trial designs like studies using multi-modal or interdisciplinary therapy approaches or studies with special forms/routes of study medication administration (drug targeting), budget control and assistance when applying for research funds and grants
  • Onsite monitoring (Risk-based)
  • Safety: SAE management, SAE second assessment, annual safety report / development safety update report (DSUR), regulatory reporting, etc.
  • Medical review and electronic/manual data cleaning
  • Excellent medical expertise in the development and design of clinical trial protocols, synopses, patient information, informed consent forms, operating- and process procedure descriptions
  • Reporting and Publishing

We have a fully implemented quality management system (QMS) including a quality manual, SOPs, sponsor oversight (vendor qualification and audits)

Our data management focuses on quality control and data integrity of the clinical study database – from database setup to database lock. We provide the specification and development of user-friendly electronic case report forms (eCRFs) based on a well-structured database to ensure high-quality data for statistical analysis.

  • Specification, eCRF design
  • Randomization support
  • Data management plan
  • Data validation plan
  • CDISC standards
  • Query management
  • Real-time data reports
  • Data validation, eChecks
  • Data cleaning

Browser-based EDC system (compliant to regulatory standards, e.g., ICH-GCP, 21 Part 11, GAMP v5)

Statistical parameters play an important role to ensure the overall success of a clinical trial. Our statistics team is therefore already involved in the planning of the study at an early phase and cooperates closely with the data management.

  • Statistical considerations of study design
  • Sample size calculation
  • Randomization
  • Statistical analysis plans
  • Conduction of statistical analysis
  • Interim analyses using adaptive designs

Statistical analysis reports

Multidisciplinary teams: Our colleagues have a background in medecine, pharmacy, human biology, chemistry, epidemiology, bioinformatics, statistics, data management and monitoring (clinical research associates)

Excellent networks: Established network of more than 300 medical institutions and the largest study groups for multicenter studies, Access to the functional units of Northwest Hospital, e.g. endoscopy, intensive care and surgery, Specialized (oncological) phase I unit in cooperation with Northwest Hospital

Industry-in-Clinic Platform: IKF provides well-established access to the routine clinical oncology environment via longterm collaborations with university hospitals and other large hospitals.

Management

Prof. Dr. med. Salah-Eddin Al-Batran

Managing Director

Office:

Tel +49 69 76 01 44 20
Fax +49 69 76 01 36 55
E-Mail: info@ikf-khnw.de

PD Dr. med. Thorsten Götze

Senior Medical Officer

Dr. rer. nat. Dennis Castor

Senior Scientific Consultant
Lead Quality Assurance Unit

Dr. rer. physiol. Claudia Pauligk

Lead Project Manager

Dr. rer. nat. Daniel Müller

Lead Project Manager

Dr. rer. med. Johanna Riedel

Lead Project Manager

Staff

Over the span of several years our work has earned us an excellent reputation in the field of oncology studies. But this is not solely a consequence of the groundbreaking scientific results we could achieve in close cooperation with our research partners. We owe our success largely to the extraordinary efforts, smartness, and sense of responsibility among our employees. Our staff is dynamic, multidisciplinary and highly experienced. The background of our employees often comprises a high degree (PhD) in medical or natural sciences. Beside medical professionals, our team comprises biologists, a human biologist, bioinformaticians, data managers, monitors (clinical research associates), a statisticians, chemists, and an epidemiologist. We speak over 10 different languages (including English, French and Italian). Members of our staff aim to form sustainable and long-term professional relationships with our partners. That enables us to meet challenges effectively. Our partners benefit from this approach as well as from the professional expertise, the sound scientific background of our employees and their excellent network and acceptance within the scientific community.

Phase-I Unit

Our cooperating phase I unit at Northwest Hospital in Frankfurt/ University Cancer Center Frankfurt offers up to 12 in- or day patient beds with full access to the intensive and emergency care units. Most patients who are treated in our phase I unit participate in phase I trials, but also phase II or phase III participants may be treated in the phase I unit in case of very complex trial procedures. The phase I unit is part of the University Cancer Center Frankfurt (UCT) and has access to associated biomarker networks like TRON, Stratifyer, the Immunological Research labs and several pathology departments etc.

Four treatment rooms with 3 beds each

A modern multi-purpose room

On site lab for clinical diagnostics and adequate processing of trial materials and specimen

Mobile IT, ultrasound and ECG equipment

Modern standard emergency equipment

In-house emergency care and both medical and surgical intensive care units

24 hours resuscitation team on duty

In-house pharmacy, institutes of radiology and interventional radiology, neuroradiology and pathology, departments for oncology and radiation oncology, central lab, endoscopy and interventional endoscopy

Network, Partners, and Supporters

Zentren germany austria switzerland italy stand 20200310

For the conduct of our phase II and phase III studies, we coordinate a national network of more than 300 medical centers and partner powerful academic research groups such as the German Gastric Group at AIO, FLOT study group, German Cancer Society, the German Rectum Study Group and others.

Our services include phase I and IIa trials as well as phase III and IV trials. In tight collaboration with our partners, the Northwest Hospital and the University Cancer Center (UCT) Frankfurt, one of the major medical centers for cancer research and treatment in Germany, we provide a modern phase I unit, fully dedicated to cancer studies and special expertise in pre-clinical and early clinical research.

Long - term collaborations

UCT – University Cancer Center Frankfurt

Medical Oncology Working Group of the German Cancer Society

Northwest Hospital

Thoraxklinik of the University Hospital Heidelberg

Our trials supported by

Institut für Klinische Krebsforschung IKF GmbH
am Krankenhaus Nordwest
Steinbacher Hohl 2-26
60488 Frankfurt am Main
Germany
Tel +49 69 76 01 44 20
Fax +49 69 76 01 36 55
E-Mail: info@ikf-khnw.de

© 2020 Institute for Clinical cancer research IKF GmbH

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