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NeuroScios GmbH

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Stockheim, DE

About NeuroScios GmbH

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

  • Alzheimer’s disease
  • Parkinson’s disease
  • Orphan neurodegenerative disorders
  • Cerebrovascular diseases
  • Psychiatric diseases

Accelerate the drug/ treatment development by our profound knowledge of the requirements

  • Pharmacology
  • ADME
  • Toxicology
  • Regulatory issues (IND/ CTA)
  • Clinical trials

Optimize the chance of success, by knowing

  • the most suitable preclinical models
  • the most experienced and reliable service providers
  • the competitive environment

Support our clients in the best way by

  • Designing most efficient individualized development plan
  • Providing an outstanding network of KOLs in different fields of CNS diseases
  • Fastest reaction time
  • Competitive pricing
  • International experience for more than 30 years

Our Services (30)


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Drug Discovery & Development

Price on request

SUPPORT FROM EARLY DISCOVERY STAGE TO CLINICAL TRIALS

  • Condensed experience for more than 30 years
  • Our experts understand and support every step of a Drug Development Program
  • Medicinal chemistry
  • Early screening
  • Target identification and validation
  • In vitro and in vivo pharmacology
  • ADME, Toxicology and safety pharmacology
  • Regulatory support
  • Clinicals trials

We know what you need – We deliver what we promise


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Phase I Clinical Trials

Price on request

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.


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Data Management

Price on request

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.


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Statistical Consulting

Price on request

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.


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Clinical Trials, Consulting, and Management

Price on request

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.


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Medical Writing

Price on request

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.

  • Study protocols and reports (Phase I-IV)
  • Investigator brochures and annual updates
  • Informed consents
  • Translation of study documents from English to local languages and back
  • Data Safety Monitoring Board (DSMB) manuals
  • Benefit risk assessment reports
  • Pre-clinical study reports, expert reports and summaries
  • Non-Clinical Safety
  • Periodic safety reports : DSUR
  • Experts opinion
  • Answers to queries from authorities

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.


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Pharmacovigilance and Post-Authorization Safety Studies (PASS)

Price on request

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:

  • Allocation of a legal representative within the European Economic Area for Sponsors based outside the European Economic Area and conducting clinical trials within the EEA.
  • Registration of Sponsor at European Medicines Agency’s Eudravigilance Database according to European Legislation.
  • We provide a responsible person for Eudravigilance, who is in charge of
    • Submission of IMP information to EMA’s XEVMPD database according to Article 57 of EC Regulation No 276 / 2004.
    • Submissions of SUSARs as ICSRs to European Medicines Agency’s EVCTM database according to European Legislation.
  • Registration of MedDRA license for Sponsor, if applicable.
  • Review and consultation for Study Protocol writing regarding safety measures.

Full SAE & SUSAR Handling:

  • Preparation, Set-Up and Implementation of SAE Report Form and Pregnancy Report Form.
  • Preparation of safety handling instructions and trainings for Investigators.
  • Full SAE handling and management from Initial to Final version, creation of CIOMS for each individual case until finalization of the event.
  • SAE follow-up requests and query handling with investigators until case resolution.
  • Assistance in DSUR preparation for Sponsor and allocation of corresponding line listings of AEs and SAEs/SARs.
  • Additional reporting of SUSARs to CAs, ECs and Investigators.
  • Allocation of a Study Safety Officer.
  • Consequent monitoring of AEs and SAEs throughout the study.
  • Study Safety Officer Medical Review of SAEs.
  • AquilaCTPV implementation - Instantaneously be up-to-date on all serious adverse events in your study at all time.
  • Instant E-Mail notifications in case of SAEs and follow-up information.
  • Organization and Set-Up of a Data Safety Monitoring Board/Data Safety Committee


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Safety Pharmacology

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CNS/Neurology Animal Models

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Imaging & Spectroscopy

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Biomarkers

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Neuroscience

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Cell and Tissue Culture

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ADME/DMPK Studies

Drug Metabolism and Pharmacokinetics
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Toxicology

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Animal Models of Disease

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Animal Models of Disease Services


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Animal Models and Studies

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Animal Models and Studies Services


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Cells and Tissues

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Cells and Tissues Services


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Bioanalysis

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Bioanalysis Services


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Biology

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Biology Services


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Pharmacology

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Pharmacology Services


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Pharmacology & Toxicology

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Pharmacology & Toxicology Services


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Data Services

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Data Services


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Epidemiology, Healthcare, and Post-Authorization Studies

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Epidemiology, HEOR, and Post-Authorization Studies Services


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Statistical Analysis

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Statistical Analysis Services


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Clinical Research

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Clinical Research Services


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Data Analysis

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Data Analysis Services


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Editorial and Writing Services

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Editorial and Writing Services


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Marketing, Communication & Graphic Design Services

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Marketing, Communication & Graphic Design Services


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Business Development, Marketing & Operations

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Business Development, Marketing & Operations Services


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Manfred Windisch

VP President R&D

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