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e-Trial Management

Today, complex clinical studies can only be conducted within a reasonable budget by consistently using modern, internet-based digital data documentation, data processing, and data management systems. Since 2000, the CRI core team has gathered in depth experience with e-trial management systems, while continuously optimising their application and their connections to all areas of a complex clinical research project.

With XClinical GmbH, we have found a technically and scientifically focussed partner whose internet-based, digital e-trial management system MARVIN meets our high expectations for clinical research projects.

The key advantages of MARVIN are

  • A very high degree of user-friendliness for the day-to-day clinical work,
  • Intuitive usability without any significant training requirements,
  • An exclusively browser-based solution with no need for on-site software installation,
  • No changes to firewall settings,
  • Fully compliant with international standards, especially CDISC and 21 CFR 11,
  • Capable of handling even highly complex study procedures and multilayer automated data exchange tasks,
  • Complete data cleaning within the system,
  • In addition to CRF data, all administrative and regulatory data and procedures are also documented and processed within one system,
  • All types of randomisation, automated material management tool, automatic notifications, on-line reports, etc.

For further information about MARVIN, please contact us or follow this link: (www.xclinical.com).

– e-Trial with a smile!

 

news-arrowNews
NOAH – AFNET 6 Study has started

Another big trial, the NOAH – AFNET 6 study, sponsored by the non-profit research network AFNET e.V. has started. By the end of June the first patient has been included. In total 3400 patients will be enrolled into this international phase IIIb study in about 230 sites in 15 European countries.

The main purpose of the NOAH - AFNET 6 study is to demonstrate that oral anticoagulation with the NOAC edoxaban is superior to current therapy (antiplatelet therapy or no therapy depending on cardiovascular risk) to prevent stroke, systemic embolism, or cardiovascular death in patients with atrial high rate episodes (=AHRE) but without atrial fibrillation and at least two stroke risk factors.

CRI is the full service lead CRO for this project and will provide all necessary services ranging from the preparation of the study protocol and eCRF to the completion of the final report; this includes also all regulatory issues, handling of contracts, data management services as well as monitoring, safety and site reimbursement.

19.06.2015 – Enrolment of the 2000th patient for EAST

By mid-June the 2000th patient has been enrolled in the EAST – AFNET 4 trial. The investigator initiated clinical trial ‘Early treatment of atrial fibrillation for stoke prevention trial’ (EAST) is currently conducted in 11 European countries with more than 100 participating study sites and compares to different therapeutic strategies for the treatment of atrial fibrillation. The trial investigates whether the course of disease of patients with recently diagnosed atrial fibrillation can be influenced in a positive manner due to early rhythm control therapy in comparison to usual care therapy. Controlled clinical trials published to date could not provide evidence that patients benefit from an early rhythm control therapy whereby rhythm control measures were applied quite late.

April 2015 SERVE-HF Study

SERVE-HF study: follow up was completed successful in April 2015. Now the final assessment period is ongoing. Firs results of preliminary analyses are available. Please visit: http://www.resmed.com/servehffaqs/index.html

01.03.2015 AXAFA-AFNET 5 Study started

International phase IV trial on the topic of catheter ablation of atrial fibrillation and anticoagulation with NOACs. About 60 study sites in Europe and the Unites States will include and follow up on about 630 Patients until mid-2017. Sponsor is the non-profit research network AFNET e.V.

CRI is the full service lead CRO for this project and will provide all necessary services in cooperation with an US based partner CRO, ranging from the preparation of the study protocol and eCRF to the completion of the final report; this includes handling of contracts, data management services as well as monitoring, safety and site reimbursement.

http://www.kompetenznetz-vorhofflimmern.de/en/axafa-trial-examines-noac-apixaban-during-af-catheter-ablation

June 2014: SERVE-HF „Major Substudy“ ends one year after end of recruitment

Slightly over a year after the end of recruitment for the SERVE-HF study the data collection for the “Major Substudy” (Substudy on the mechanistic plausibility of the clinical benefits of adaptive servo-ventilation) has come to a close. The required number of follow-ups with the accompanying imaging techniques has even been surpassed by far. The follow up of all patients in SERVE-HF will continue until mid-2015 and analysis of the data will have to wait until after this time point. First published results are expected in the fall of 2015.

25.04.2014 Start of Clinical register to rare microangiopathy (CESAR)

Rare diseases can generally only be detected and observed in larger clinical registers. This also applies to the diagnosis of rare thrombotic microangiopathies. The goal of this epidemiological study is to find out the frequency with which bacterial infections or bleeding disorders are the cause and whether other clinical factors may be of aid for the differential diagnosis. We expect to document about 300 patients until April 2016.

24.01.2014 Start of Europe-wide clinical registers for portable defibrillator vest (WCD) (WEARIT II Europe)

It is being studied under regular treatment conditions, whether the WCD may temporarily protect potentially vulnerable patients. This is, for example, necessary after acute myocardial infarction when the pumping function of the heart is severely limited and, consequently, life-threatening cardiac arrhythmias can occur. On the other hand, the spontaneous recovery of heart failure is possible.The register 700 patients will be documented and tracked until January 2017.

CRI is the full service lead CRO for this project and will provide all necessary services, ranging from the preparation of the study protocol and eCRF to the completion of the final report; this includes handling of contracts, data management services as well as monitoring, safety and site reimbursement.

04.11.2013 – 1000. Patient randomised for EAST

In the beginning of November 2013 the 1000. patient was randomised in the AFNET-EAST trial. The EAST study („Early treatment of atrial fibrillation for stroke prevention trial”) is ongoing in 11 European countries and compares two different therapeutic strategies for atrial fibrillation.

EAST demonstrates that independent, investigator initiated studies are essential to gain scientifically relevant knowledge in the clinical research.

Many issues of medical treatment like those studied in EAST would not be investigated in commercial trials.

Again the team of CRI demonstrates its great expertise in design, set-up and  implementation of international “Investigator-Initiated-Trials” (IITs).

31.05.2013 –international SERVE-HF reaches recruitment target

Recruitment for the study “Treatment of sleep-disordered breathing with predominant central sleep apnoea by adaptive servoventilation in patients with heart failure” (SERVE-HF)” was completed on 31.05.2013.

The follow-up period for the 1.325 randomized patients from 10 European countries will be two years.

The CRI Team has mastered the challenge to coordinate two different medical fields (sleep medicine and cardiology) in a parallel randomized trial despite many procedural and logistical challenges.

Experts eagerly await the result of the study.

18.02.2013 - EAST

Today the 600 patient is included in our EAST study. The study is already running in 8 European countries.

26.04.2012 – 1,000th patient in SERVE-HF

Today, the 1000th patient was included into our SERVE-HF study. This controlled clinical endpoint study aims to find out whether patients with central sleep apnea and associated heart failure benefit from a adaptive servo ventilation at home in the long term. Approx. 250 study sites in 9 European countries and Australia are participating in SERVE-HF. 

CRI is the full-service lead CRO and has partnered with an Australian CRO to provide all required services to the project; these include the design of the study protocol and e-CRFs, all regulatory proceedings, management of contracts with study centers and other involved parties, project- and data management as well as monitoring, safety, handling of fees and production of the final report

20.03.2012 - Second GCP audit

Another major international study project in which CRI acts as a full service CRO, was audited on behalf of the sponsor. Objective of the audit was to assess whether the established processes  comply with the requirements of ICH GCP and applicable legal requirements. We are pleased with the positive evaluation  and the progress of the study.

24. – 27.01.2012 – First GCP audit

Just under 10 months after the opening of the institute, CRI has passed its first GCP audit well. A large international sponsor engaged an independent auditor to evaluate their CRI-conducted project, as well as all relevant procedures at CRI – there was no major complaint. We are pleased with this outcome and feel encouraged to continue on our way.

01.09.2011 – CRI moves into its new office in the Renaissance House in Munich

After a long search and extensive alterations, CRI has now moved into its new office. The Renaissance House offers a pleasant surrounding combined with modern infrastructure – and excellent connections to the Central Railway Station as well as all to city trains (“S-Bahnen”). Located on the 5th floor, we enjoy an unrestricted view over much of Munich and look straight at the Alps – a panoramic vista that clears the mind for innovative tasks.

28.07.2011 - FPI in EAST

With the participation of 200 study sites across 11 countries, this controlled clinical endpoint study aims to find out, wether patients with atrial fibrillation will benefit from an early rhythm-sustraining treatment in the long term.

Sponsor is the non-profit research network AFNET e.V.
CRI is the full service lead CRO for this project and will provide all necessary services, ranging from the preparation of the study protocol and eCRF to the completion of the final report; this includes handling of contracts, data management services as well as monitoring, safety and site reimbursement.

01.04.2011 – CRI starts its activities at the Regus Business Cente

The Clinical Research Institute with its initially small team has started its operations. The first project contracts have been signed or will be signed soon. To ensure that the Institute will be able to conduct international projects comprehensively and according to industry standards in the near future, it is planned to rapidly grow the CRI team.