We employ physicians, study nurses, project managers and trial coordinators, data managers, statisticians and quality control managers, as well as recruitment personnel. All personnel undergo constant training on all the current legal and organizational aspects of clinical trials.

CTC North has its own study ward with 35 beds on the campus of the University Medical Center Hamburg-Eppendorf (UKE) (10 beds are used for continuous cardiovascular monitoring), which are available to trial participants and patients within the framework of clinical trials. As we conduct our own clinical trials on our study ward, our employees are trained on current regulations governing clinical trials and have first-hand experience in their implementation. All consulting carried out for clinical departments at the UKE by us is therefore backed up by direct experience.

 

Clinical trials include all scientific studies carried out in healthy volunteers and in patients, in which drugs or medical devices are tested or scientific data is compiled. A core team of physicians and other professionals maintains close contact with national and international authorities (Federal Institute for Drugs and Medical Devices (BfArM) or the Paul Ehrlich Institute (PEI) in Germany, the European Medicines Agency (EMA) in Europe), with regard to counselling, performance and implementation of clinical trials according to the Guidelines on Good Clinical Practice (GCP).

Consulting

Consulting

We offer advice and consulting in the field of clinical research, particularly in conducting and planning of clinical trials with investigational drugs or medical devices.    

Feasibility

Feasibility

  • We are a professional partner for study proposals and feasibility requests of all indications that are sent to CTC North or the University Medical Center Hamburg-Eppendorf (UKE). 
  • Fast, efficient contact is made via us with the centers and clinics of the UKE or any other practice/hospital or study that needs to be involved.
  • Quick and, above all, realistic estimates of recruiting potential and rational timelines for all indications based on the inclusion and exclusion criteria of your trial protocol.
  • Short processing times of transparent feasibility analyses and offers event-based cost models.

Recruitment

Recruitment

We are located on the campus of the University Medical Center Hamburg Eppendorf (UKE) and this location is one of our greatest advantages in planning, recruiting and conducting clinical trials.

Other advantages are the number and structure of the population in Hamburg and its Northern German surroundings from which healthy volunteers and patients are recruited. Our long-term cooperation with colleagues from various UKE departments and a variety of practice networks have produced very good results.

Various methods are used to recruit trial subjects. These methods include advertising in local daily and weekly papers, use of social media, placing notices in pharmacies, in the many universities in Hamburg, and advertising on local transport services. In addition, CTC North operates an own call-center and has a steadily increasing database of trial patients and persons interesting in taking part in trials.

We suggest our recruitment methods after assessment of their prospects of success, based on the experience of all members of staff involved in trials. The strategy of the advertising campaign is discussed with the client in advance.

The advertising campaign is then launched after permission has been granted by the ethics committee responsible for the trial.

Study Conduct

Study Conduct

CTC North has a study ward with 35 beds on the campus of the University Medical Center Hamburg-Eppendorf (UKE) (10 beds are used for continuous cardiovascular monitoring), which are available to trial participants and patients within the framework of clinical trials.

As we conduct our own clinical trials on its study ward, all our employees are trained on current regulations governing clinical trials and have first-hand experience in their implementation. All consulting carried out for clinical departments at the UKE by us is therefore backed up by direct experience.

 

Experience & Expertise

 

  • Carrying out phase I-IV clinical trials from „first-in-man“ to „proof-of-concept“, with interlinking between healthy trial participants and early clinical patient trials. 
  • Complete phase I trial surroundings with a highly experienced core team equipped with state-of-the-art technology
  • Integrated research plans for the same medication permit interconnection between phase I and phase II-IV trials, resulting in shorter timelines for authorization/licensing, thus creating a combination of „Early clinical research“ and „Late stage development“.
  • Complex PK/PD experience for early phase trials
  • -20, -70 freezers, refrigerated centrifuges, micro pipettes
  • Experienced in numerous EDC and IVRS/IWRS systems 
  • Rapid query resolution
  • Spacious in-patient rooms
  • Kitchen with dietician for controlled meals
  • Patient day room with satellite TV and various recreational activities
  • Vast experience in many indication with 5 trained investigators
  • 24-hour nurse coverage and 24/7 physician coverage
  • Long term archiving

Regulatory

Regulatory

Our project managers provide independent, objective leadership for your trial. Their broad-based medical expertise provides scientific credibility to your trial. Their depth of expertise in clinical trials allows your trial to move forward smoothly and within the timelines.

Experience & Expertise

 

  • Preparation of submission packages
  • Preparation of templates and collection of site specific documents for regulatory submission
  • Regulatory submission and communication
  • Annual safety reporting

Project Management

Project Management

Our project managers are fully committed and deeply involved in all project related activities. They are the lead and the guide of the project team and the key person for planning of all project related activities, defining communication lines and interfaces, ensuring adherence to timelines, quality and the budget. 

Proactive attitude, hands-on approach, flexibility, reliability and the right balance between science and common sense are just some of the characteristics of our team.

  • Trial master file set-up and maintenance
  • Investigator site file set-up
  • Site and laboratory qualification
  • Site contracting
  • Investigator meetings
  • Site management
  • Project Ttmelines
  • Identifying potential investigational sites (phase I, hospital, doctor’s surgery)
  • Evaluation of the overall budget per investigator or study site
  • Development of study documents (essential and regulatory documents)
  • Management and logistics of the study materials and study documents
  • Preparation and publication of study meetings newsletters
  • Regular reporting to the client

Monitoring

Monitoring

Our clinical monitoring group is highly experienced in all monitoring related activities. Our CRAs/Lead CRAs are responsible for and committed to conducting all activities in accordance with the protocol, ICH/GCP/ISO14155 requirements, the project specific monitoring manual, applicable SOPs and all additional regulatory requirements.

Considering different monitoring strategies we are able to plan an intelligent and effective project specificmonitoring plan which fits your needs.

 

Experience & Expertise

  • Investigator initiated and industrial trials
  • AMG and Medical Device trials
  • Phase-I-IV monitoring
  • Approval trials with up to 3000 subjects, more than 60 sites in 9 countries
  • Various indications
  • Determination of study specific risk profile and adapted monitoring plan
  • Detailed and transparent calculation of study specific monitoring effort
  • Study setup support
  • Site selection, initiation, monitoring and clos out visits
  • Source data verification (SDV)
  • Electronic- and paper-based case report form monitoring
  • Safety and quality analysis
  • Status report
  • Site support and site coaching

 

 

Data Management

Data Management

We provide full data management services for all types of studies – drugs, medical devices, from routine phase I trials through to complex phase III trials.

Our experienced data management team ensures that the clinical data in your project is collected and managed reliably, efficiently and in compliance with all standards and regulatory requirements. Our data management services offer maximum flexibility for conducting clinical trials with EDC, paper CRFs or a combination of both.

 

Experience & Expertise

 

  • CRF design and development 
  • Printing/assembly/distribution of CRFs
  • Data management plan Creation
  • Data Entry Screen Design and creation
  • Database design and programming
  • Double data entry
  • Programming of edit checks and data listings for data validation
  • Coding of diseases, adverse events and medications
  • Query management
  • Standardized and customized status reports
  • Support for medical review and SAE reconciliation
  • Integration of data from other sources
  • Patient reported data (diaries)
  • Creation of CDISC SDTM datasets

Statistics

Statistics

Our biostatisticians have the education and industry experience necessary to execute a data analysis strategy for your studies. 

They also have extensive knowledge of statistical methodology for drug and device development, various study designs, and regulatory requirements. They are experienced in a broad range of therapeutic areas. Our sponsors appreciate the reliability and the proactivity of the team.

 

Experience & Expertise

 

  • Planning and analysis of Phase I – III Studies
  • Study design
  • Statistical input into study protocol/observational plan
  • Sample size estimation
  • Randomization
  • Statistical analysis plan, table plan, table shells and analysis dataset specifications
  • Statistical data review
  • Analysis, e.g. interim and final analysis, PK and PK/PD snalysis, integrated summary
  • Representation of clients in meetings with regulatory authorities  

Medical Writing

Medical Writing

Our medical writers work to integrate the medical and statistical results of your trial into an electronic or paper document that meets the needs of the client and the regulatory requirements.  

Experience & Expertise

 

  • Generation of clinical study protocols
  • Development of subject’s information, informed consent form and other study documents (e.g. patient's diary)
  • Writing of clinical study reports
  • Publications support

 

Our specialists prepare documents for publication or integration into larger submission documents. They convert the components of the document into pdf format and perform the tasks of paginating, bookmarking and hyperlinking the pdf document.

Quality Assurance

Quality Assurance

Good Clinical Practice (GCP) is an internationally recognized ethical and scientific standard for designing, conducting, documenting and reporting clinical trials that involve the participation of humans.

Compliance with this standard ensures public assurance that the rights, safety and well-being of the trial subjects are protected consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical data are credible.
Quality assurance in clinical trials is one of our main tasks.

We ensure

  • That all our (study) personnel is well-trained
  • That all parties involved receive comprehensive information on their tasks and that they are fully aware of the importance of quality in clinical trials
  • The establishment and strict observance of suitable operating procedures
  • The generation of trial documentation according to the requirements of the sponsor.

In the ICH-GCP glossary, quality assurance is defined as a process in which „all planning and systematic measures are implemented to ensure that trials are conducted and data is generated, documented and reported in compliance with the guidelines on GCP and applicable regulatory requirements“. Quality control includes all operation techniques and activities undertaken within the quality assurance system to verify that all requirements relating to the trial quality are fulfilled. Monitoring is „the act of overseeing the progress of a trial, and of ensuring that it is conducted, recorded and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) and the applicable regulatory requirement(s).”


In order to guarantee these requirements, we have developed a quality management system that has been certified according to DIN EN ISO 9001-2008 by German Lloyd in 2006. The certification was re-confirmed by regular audits.


With a very positive response from clients in the pharmaceutical industry, CTC North meets the highest demands on reliability, data quality and compliance with recruiting and timelines required in controlled clinical trials.

Safety Management

Safety Management

Patient safety is critical to every study. We offer a complete range of Safety Management services for your project.

Experience & Expertise

  • Writing/review of relevant sections of the study protocol
  • SAE and AE review
  • SAE case processing and preparation of SAE narratives
  • Safety database management
  • Reporting of SUSARs to regulatory authorities and ethics committees
  • Development safety update reports (DSURs)
  • Set-up of a medical monitoring for your project
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