Phase I Unit

From “first-in-man“ to “proof-of-concept”

Our state-of-the-art facility provides outstanding medical capabilities. We have 35 beds (thereof 10 beds with intensive monitoring capabilities), 8 examination rooms, on-site specimen processing lab, biological sample refrigerators and freezers, fully equipped intensive monitoring suite and secure record and drug storage space. We also have an infusion room, ECG, spirometry, pulse oximetry, emergency equipment, and are embedded the emergency chain of the University Hospital.

When choosing a partner for your early phase clinical projects, you need an expert. Our sponsors can therefore be certain that the quality and expertise of our facility is second to none.

CTC North has conducted studies across a broad spectrum of medical specialties. Our Phase I unit is designed to conduct studies in healthy volunteers and in special patient populations. In addition, the strategic location of our facility on the campus of the Medical University Center Hamburg ensures maximum safety and provides:

  • Immediate emergency cover on site
  • Modern imaging and diagnostic techniques
  • Well-defined subject populations (e.g. elderly, post-menopausal, impaired liver function, pediatric)
  • Well defined disease groups (e.g. cardiovascular, respiratory, neurological, gastrointestinal, urological, metabolic and psychiatric)
  • Academic and scientific experts and KOLs
  • Fast medical care through specialists in the event of serious adverse events
  • Fully equipped and staffed clinic with 35 beds
  • Intensive care unit with 10 beds
  • 22 PSG beds for sleep studies in cooperation with 2 sleep centers
  • Full service pharmacy
  • In-house laboratory
  • Recreational area and dining room for patients and volunteers

IITs

Investigator-Initiated-Trials

Academic clinical trials are essential for clinical research especially for optimizing patient treatment.

Even though the legal responsibilities, tasks and duties are the same, IITs are special due to the fact that the financial budgets are in general limited. The peculiarities and difficulties have to be considered, an optimal planning from the very first moment is mandatory in order to perform and finalize them successfully.

Application for funding / calculation of clinical studies

Application processes for public funding (public grants) is often a very time consuming; funding decisions are made within a years’ time frame at a minimum. In this early phase, CTC North already offers support for the calculation and planning of clinical studies. A sound calculation of the planned clinical trial including costs for contingency plans is the basis for a reasonable funding application and avoids that the study has been calculated too tightly and cannot be finalized.

Our approach is to discuss and decide together with the sponsor which tasks can be performed by the sponsor in case the financial resources are limited and which tasks we suggest should be overtaken by experts in order to guarantee an ideal use of the financial and personnel resources.

The primary objective during the planning and conduct of clinical trials is the identification of potential risks and minimizing them.

Experience of CTC North

We have many years of broad experience in planning, management and conduct of IITs as well as in public funding applications. Therefore, problem-solving approaches for all conceivable challenges are included in our actions that supports to finalize clinical trials successfully.

Besides conducting Phase I studies in both healthy volunteers and patients since 2006, we have also performed more than 60 phase II–IV trials (including medical device trials) with patients while acting as a study site within multicenter clinical trials. These experiences added valuable know-how to CTC Norths principle investigators, study nurses and project managers. Thus, our personnel does not plan studies theoretically. They do exactly know which difficulties and challenges can occur during the conduct of clinical trials, e.g. complicated and not clearly defined protocols, extensive documentation, complex in- and exclusion criteria, misjudgment regarding recruitment performance, etc. They help and support qualified based on their longtime experience within the conduct of clinical trials.

 

The Clinical Trial Management division has a long term experience in the organization and coordination of multicenter Investigator-Initiated Trials in several indications. CTC North has conducted more than 60 single- and multicenter trials during the last 8 years, about the half of them were IITs.

Services of the department Clinical Trial Management for Investigator-Initiated-Trials

These services can comprise the entire process of a clinical study from the very beginning e.g. support during application of public grants, development of the study protocol until final report. However, all services can be provided separately.

We are able to offer all services for preparation, organization, coordination and management of clinical trials, which that means in particular:

 

•            Consulting and support during application of public funding

•            Project management

•            Site Management

•            Regulatory affairs

•            Medical writing

•            Safety management

•            Monitoring

•            Data management

•            Statistics

 

This range of services applies for national clinical trials as well as for European projects. Currently, CTC North is partner in an EU (Horizon 2020) funded clinical study project and is subcontracted for clinical trial services in two projects funded under the FP 7 Health program.

Also in our focus is the provision of advisory services to investigators and research scientists at the UKE and other university hospitals as well as to pharmaceutical and medical device companies in Germany.


contact

 

Saskia Borregaard, PhD

Director, Clinical Trial Management

 

Tel.: +49 40 524719 200

Fax: +49 40 524719 119

 

E-Mail: s.borregaard@ctc-north.com

University Environment

University Environment

Being located on the campus of the University Medical Center Hamburg-Eppendorf we are in a perfect position to provide services in research and development, as well as being an ideal partner for the industry.

 

The central location of the CTC North and its proximity to the University Medical Center Hamburg Eppendorf (UKE) is one of our greatest advantages in planning, recruitment and conducting clinical trials.

 

 

 

 

Medical Devices

Medical Devices

Medical device manufacturers are facing increasing requirements by regulatory agencies. The recent amendment to the EU Medical Device Directive, has further tightened the requirements for performing clinical studies yielding supporting data.

Thoroughly familiar with these current EU Guidelines and the corresponding implementation in German law (MPG) in accordance with ICH-GCP, we can offer distinctive know-how for clinical trials with medical devices:

 

• Study planning, setup, site selection

• Protocol writing and review

• Regulatory submission

• CRF/eCRF development

• Project management and logistics

• Imaging Core Lab facilities including QC and blind read of imaging data

• Site management, contract management, site reimbursement

• Monitoring

• Data management

• Statistical analysis

• Medical writing

 

We know the resource challenges that many medical device companies face. Our business processes and experienced staff help us be efficient and cost-effective, while providing a personal approach. Whether you need full services or only one particular service offering like data management or monitoring, our team of experts will help.

Depending on the class and the risk potential of a medical device, the verification for market authorization can render a trial under (almost) clinical conditions necessary.

For clients who are confronted with this challenge, the experience and expertise of our team in the scope of clinical trials are at your service.

Acting SMO

Acting SMO

Our internal study site (Site Management Organisation) conducts clinical trials of all phases for various indications. A motivated network of medical specialists, a large database of healthy volunteers and patients as well as systematic advertising guarantee an efficient patient recruitment.

As our staff is highly experienced and regularly trained in ICH-GCP and all other relevant laws and guidelines, study conduct and documentation quality are on the highest level.

 

Experience & Expertise

 

• Feasibility analysis

• Input to the study protocol

• Active recruitment of patients (network of medical specialists and hospitals, large database of patients, systematic advertising in print and social media)

• Short recruitment periods

• Professional guidance and supervision of patients

• Good compliance

• ICH-GCP trained study personnel

• High quality of documentation

Phase II to IV Trials

Phase II to IV trials

  • Conducting clinical phase II to phase IV and medical device trials in a university setting.
  • Close cooperation with research specialists.
  • A team of highly qualified and experienced investigators and study nurses.
  • A network of general practioners.
  • Data management services.
  • Study coordination
  • Close collaboration with clinical and research specialists at the UKE and other institutions in the Hamburg area

Experience & Expertise

  • Feasibility analysis for clinical trials

  • Biometric planning

  • Development of study design and study protocol

  • Development of paper-based and electronic Case Report Forms (CRFs)

  • Preparation of all study related documents

  • Recruitment and selection of study sites

  • Contract negotiations with study sites

  • Request for authorization at competent authorities - BfArM/PEI

  • Regulatory submission to responsible national Ethics Committees (EC) and responsible local ECs

  • GCP training for study personnel

  • Planning and conducting of investigator meetings

  • Monitoring

  • Payment of investigator and study personnel fees

  • Data management

  • Statistical analysis

  • Medical Writing (Study Protocols, Patient Information / Informed Consent Form, Clinical Study Reports)

  • Safety Management

Indications

Our experience in following indicational fields

 

 

 

 

CTC NORTH GMBH & CO. KG

at the University Medical Center Hamburg-Eppendorf

Martinistr. 64 ⋅ 20251 Hamburg, Germany

T +49 (0)40 52 47 19-0

info@ctc-north.com