NeuroScios GmbH
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Stockheim, DE
With 30 years of experience in CNS drug development we may offer you the fastest track from molecule to clinic. As a contract research organization we
Support the development of new treatments for CNS diseases
Accelerate the drug/ treatment development by our profound knowledge of the requirements
Optimize the chance of success, by knowing
Support our clients in the best way by
SUPPORT FROM EARLY DISCOVERY STAGE TO CLINICAL TRIALS
We know what you need – We deliver what we promise
Phase I Clinical Trials are the fundament of a clinical drug development program.
25% of our clinical trials were Phase I trials. Since more than 30 years we design drug development programs exactly to the needs of our clients. Our services include strategic considerations, medical writing, statistical planning, study conduct, project management, monitoring and more. Our large scientific network of connects you with opinion leaders, investigators and international experts with a special focus on neurodegenerative diseases or other indications as needed. Throughout Central and Eastern European Countries our investigator network provides you access to your targeted patient population or special population groups. In addition we offer access to Phase I units which are able to meet your requirements. The Neuroscios specialists are familiar with regulatory procedures in Central and Eastern European Countries.
As safety is the primary endpoint of a Phase I clinical trial you would like to have the strong pharmacovigilance team of NeuroScios. In addition Neuroscios is able to set up a Data and Safety Monitoring Board (DSMB) to ensure periodic medical review and ensure subject safety - and guarantees you the opinion of true experts.
Our data management team is led by a number of highly-experienced and technical project managers who are responsible for the quality and successful delivery of all data management tasks and deliverables. They use 'state-of-the- art' data management support tools as part of our 'in-house' CDMS system. We can also enable secure, remote access and usage through our cloud based setup.
Our Data Management services include: CRF design, EDC data review, Manual 'double key' data entry (with query generation, resolution, reporting and full audit trail), Data importing to SAS for derivation and structuring prior to analysis, Data coding with (WHO/MedDRA dictionaries) as well as Quality control.
Our industry-leading Clinical Data Management System (CDMS), dataKaptureTM is built on the latest industry standard Microsoft platforms (.Net, HTML5, Silverlight and SQL) and is integrated with SAS software. The CDMS is fully validated, documented and compliant with CFR 21 part 11.
The platform provides clients direct access to real-time data reporting, with interactive graphical review, patient profiling and trend assessment. It is a fully-enabled system that is suitable for data collection using both electronic (EDC, digital pen. tablet/iPad, ePRO and IVRS) as well as manual (traditional paper) CRF books.
Our team has experience across all phases of clinical development and most therapeutic areas, which provide familiarity with all sorts of databases and CDISC SDTM and ADaM structures. We have particular expertise with databases from PK/PD investigations, health economics, hospital registries and post-marketing safety monitoring trials. However, underlying this breadth of experience is our core focus and primary interest which remains neuro-cognition.
Our highly experienced statistical team has been advising clients on whole clinical development programmes in the CNS area for many years. We can help with ‘Proof of concept’, Dose ranging or even with Adaptive designs and Interim analysis aspects during the phase II 'learning' process as well as consultation on designs for 'confirmatory' phase III programmes.
Our statistical services include: Protocol design, Sample size investigations, Development of statistical analysis plans and table shells, Application of analytical methods and Production of stand-alone statistical reports or consolidated Clinical Study Reports.
We routinely integrate databases from multiple projects, undertake meta analyses and create Integrated Safety Summaries. We are also regularly involved with DSMB's providing Data Reviews and Interim Analyses. We provide expert reports and 'state of the art' publication and presentation services.
Our particular strengths are: Adaptive designs:, Repeated measures mixed model analyses of time series data, Non-linear mixed modelling analyses of sparse data, Meta-analyses (Fixed and Random effects) for the combination of treatment estimates from individual trials and Survival analyses.
Neuroscios has over 30 years of experience in drug development and 15 years of experience in the conduct of clinical trials with a strong focus on neurodegenerative diseases. This experience might make the difference between success and failure of your clinical trial.
Starting with the protocol, Neuroscios team will provide you with the necessary ingredients to prevent failure due to wrong planning, the wrong choice of clinical sites and bad study management.
A strong team of specialist in regulatory affairs throughout Europe will submit your study to IRBs or competent authorities in the countries of your choice. Neuroscios offers experienced project managers, senior CRAs, CRAs and CTAs. All CRAs have a scientific background or are nurses.
Throughout the study the Neuroscios team will support your trial trough overtaking all necessary tasks like site management, drug management, monitoring, and vendor management and will help with patient recruitment.
Medical writing accompanies a compound from the very first steps of drug development starting in the laboratory trough in vivo testing and toxicology, clinical trials till market release and during the whole lifetime of a drug.
NeuroScios provides medical writing services for all stages.
The quality of these documents plays a critical role in the success of clinical trial submissions and finally the failure of new compounds and devices.
NeuroScios has more than 30 years of experience in the field. Our team of experts, statisticians, clinical researchers e.g. help to develop the research protocols in clinical studies in order to get the best strategic outcome for either new studies or a final marketing authorization.
All of our medical writers have a background in biology, pharmacology and medicine. We understand the regulatory process in all Central European and Eastern European Countries and the required documentation demanded by Good Clinical Practice, which encompasses the scientific and ethical standards that must be followed in any study involving human subjects.
During the life time of a drug constant work on pharmacovigilance including literature research is necessary. NeuroScios’ own pharmacovigilance department is able to provide safety reporting including case reports and literature Research.
Different standards and requirements apply to clinical trials conducted within the European Economic Area. With our expertise in the specific field of pharmacovigilance we are putting our focus and intentions on ensuring subject safety and guaranteeing to fulfill all necessary regulatory requirements when conducting clinical trials within the European Economic Area.
SERVICES
Management:
Full SAE & SUSAR Handling:
Animal Models of Disease Services
Animal Models and Studies Services
Cells and Tissues Services
Bioanalysis Services
Biology Services
Pharmacology Services
Pharmacology & Toxicology Services
Data Services
Epidemiology, HEOR, and Post-Authorization Studies Services
Statistical Analysis Services
Clinical Research Services
Data Analysis Services
Editorial and Writing Services
Marketing, Communication & Graphic Design Services
Business Development, Marketing & Operations Services
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