Clinical Research: Late Stage Development - read more

AMS  is your experienced partner for PASS, PAES, Registries, RCT, and Patient Outcomes Research. AMS  NIS-specialists give advice in NIS-rationale and Observational Plan set-up, making sure:

  • NIS rationale fits existing and future legal expectations
  • NIS concepts ideally support Medical Affairs‘ responsibilities and targets

Epidemiologic services at AMS  include observational studies of risk factors, drug utilizations and adherence, Clinical Safety, comorbidities, and natural history of disease.

AMS  assists you in evaluating the most appropriate study type for the design of your study.

 

For non-interventional studies:

  • Regulatory requirements within the EU are quite complex - AMS  Regulatory Affairs team has experience with national, European and international studies and guides you through the approval and notification requirements, including registering your study and its results in public registries,
  • performing applications to regulatory authorities and data protection agencies as well as notifications to competent authorities or health insurance companies (if needed), and
  • Submission to the Ethics Committee: AMS  supports you in selecting the main Ethics Committee and supports your sites in submitting to their local Ethics Committee
  • Data protection is one of the most challenging topics and our data protection officers are fully aware of the current requirements for study documents.

Moreover, AMS  well-trained project managers can support in preparation and conduct of site audits – whether intended by you or competent authorities.

 

Find out, how AMS  Clinical Research services fit to your needs:

Talk or write to us:

• 2011 – AMS AMNOG Services pioneer • 2013 – AMS-Investigator SELF-TRAINING PORTAL • 2013 – “BEST CRO” by one of the world’s Top 5 Pharma companies’ CRO Evaluation for AMS – Clinical Operations Services • 2014 – AMS performs Medical App Studies including eCRF-data integration • 2015 – AMS Medical Science is awarded “Provider of the Year, worldwide” by one of the world’s Top 10 Pharma companies • 2015 – AMS develops an E-feasibility tool • 2015 – Innovative Tool for Patient Reported Outcomes: AMS ePro (BYOD-type PRO solution) is developed • 2016 – AMS – Regulatory Affairs is nominated on the short-list for TOPRA Award for Regulatory Excellence

News

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    EMA-EUnetHTA Parallel Consultation

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    Artikel vom 01 August 2017 News
    Profit from the simultaneous feedback of regulatory and HTA bodies in order to generate your data set in the most efficient way! What is new? EMA and EUnetHTA h...
  • AbbVie TRIUMPH AWARD 2015

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    Um Kooperationen auszuzeichnen und Partner entsprechend zu honorieren, verleiht AbbVie Global jährlich den Preis 'Supplier of the Year'. Kriterien, um für den P...
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