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Consulting

We support the realization of your trial plans

Our team of specialists will consult you from first trial concept discussion through successful set-up of your trial.

Take AMS on bord early during concept discussion of your planned trial. Our cross-departmental teams of highly experienced clinical research specialists supports your concept set-up to be suitable to reach its targets, being cost efficient and provide the required data in time.

Our Design and Consulting group consists of Senior Medical Doctors, Senior Biostatisticians, Senior Medical Writers, Clinical Operations & Data Management Specialists, Drug Safety Medical Experts and Senior Regulatory Affairs Managers.

Contact us early for ideal support.

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Latest News Enhanced

  • Startseite

    Flagline AMS Advanced Medical Services GmbH Die Team Company AMS ist bereits seit 1997 kompetenter Partner Dienstleister der Pharma- und HealthCare-Industrie in den Geschäftsbereichen Klinische Forschung, Marketing & Sales sowie Training / 1. Internet-Pharmaschule (1.IPS). Lesen Sie hier weiter über unsere Entwicklung. Als erfahrene CRO (Contract Research Organization) bietet AMS mit der Klinischen Forschung ein umfassendes Leistungsspektrum von den Klinischen Studien der Phasen 2, 3, 4 sowie NIS, Datenerfassung, Datenmanagement, Biometrie, Pharmakovigilanz / Arzneimittelsicherheit und Medical Writing bis hin zur Qualitätssicherung und der Durchführung von Audits sowie der Unterstützung im Bereich Regulatory Affairs und Zulassung. Lesen Sie hier weiter über unsere Klinische Forschung und unsere Leistungen. Unsere Medical Science Gruppe ist seit Inkrafttreten des Arzneimittelmarktneuordnungsgesetzes (AMNOG) im Jahre 2011 Pionier im Bereich Nutzendossiers für Arzneimittel und arbeitet seit Jahren erfolgreich mit 8 der 10 marktführenden Pharmaunternehmen zusammen. Durch unsere umfassende Erfahrung im Bereich Arzneimittel sind wir auch ein starker europäischer Partner im Bereich Health Technology Assessments (HTAs), Pilot Rapid Relative Effectiveness Assessments (REAs) und auf dem Gebiet der Nutzenbewertung von neuen Untersuchungs- und Behandlungsmethoden mit Medizinprodukten in Deutschland. Weitere Informationen erhalten Sie unter Medical.Science@ams-europe.com Marketing & Sales bietet von der von der profildifferenzierten Rekrutierung und Arbeitnehmerüberlassung von Leasingaußendienstlern (Pharmaberater, Pharmareferenten, Fachreferenten, Klinikberater, Key Account Manager (KAM); Apothekenverkäufern und Medizinprodukteberatern bis hin zur Bereitstellung kompletter Leihaußendienste in strategischer Partnerschaft als CSO (Contract Sales Organization) ein umfassendes Spektrum von individualisierbaren Leistungen, die sich konsequent an dem Bedarf und den Bedürfnissen unserer Auftraggeber orientieren. Lesen  Sie hier weiter über Marketing & Sales sowie über unsere Leistungen. Auch im Bereich Training ist das Spektrum unserer Leistungen weit gespannt. Es reicht von Online-Schulungen über Präsenzseminare bis hin zu Coachings on the Job. Unsere 1. Internet-Pharmaschule ist seit 2001 bewährt und überaus erfolgreich in der Ausbildung von Geprüften Pharmareferenten wie auch in der Durchführung von Produktschulungen und Außendienstschulungen. Unsere Online-Weiterbildung Medical Education Training für Klinische Monitore (CRA), Medizinprodukteberater, Produktmanager Pharma und Pharmaberater ohne fundierten medizinischen Bildungshintergrund (z.B. Chemiker, Biologen, Biochemiker, Oecotrophologen, BTA, CTA, Ingenieure, Ökonomen u.v.a.m.) basiert auf unserer langjährigen, erfolgreichen Erfahrung in der Online-Ausbildung von Geprüften Pharmareferenten. Verkaufstrainings und Führungskräfte-Coachings erfolgen in Präsenz und „On the Job“. Lesen Sie hier weiter über unseren Trainingsbereich und unsere Trainingsleistungen in der Klinischen Forschung und in Marketing & Sales.    
  • Consulting

      Consulting We support the realization of your trial plans Our team of specialists will consult you from first trial concept discussion through successful set-up of your trial. Take AMS on bord early during concept discussion of your planned trial. Our cross-departmental teams of highly experienced clinical research specialists supports your concept set-up to be suitable to reach its targets, being cost efficient and provide the required data in time. Our Design and Consulting group consists of Senior Medical Doctors, Senior Biostatisticians, Senior Medical Writers, Clinical Operations & Data Management Specialists, Drug Safety Medical Experts and Senior Regulatory Affairs Managers. Contact us early for ideal support.
  • Medical, statistical and regulatory consulting

    Consulting Find the right Trial Concept The early concept of your trial is a key deciding factor on timelines, costs and quality of your trial. Let us contribute to your concept for your success. Involve our AMS Medical Team, as well as the specialists from our AMS Medical Science team and our Regulatory Experts early into your discussions on new project plans. From our exceptional experience, our specialists are able to guide you and your team to find the right trial concept. Your benefit will by robust timelines and budgets as well as an increased likelihood to reach your target in time. Early consultancy services are provided by AMS independent from the full project work  order as a modular service.
  • Protocol development

    Consulting Benefit from our exceptional expertise Our extraordinary Medical Writing capabilities will support ideal trial concepts. You will feel the difference. The AMS Medical Writing and Biostatistics will guide you from early protocol concept through to final Clinical Trial Protocol. We support your Competence Autority Advice and support target-driven data collection. With an extraordinarily large Medical Writing team, AMS is able to supply the ideal Medical Writer and Biostatistician to collaborate with you and your team in the set-up of your Clinical Trial Protocol or Observational Plans.    •    Statistical input into study design and protocol development    •    Adaptive study designs    •    Sample size calculations    •    Identifying the primary endpoint    •    Setting up randomisation schemes    •    Observational and epidemiological studies
  • Country- and Site Selection

    Consulting Be informed about the differences to decide the right way Be aware of country- and site specific differences. Your AMS Clinical Operations and Regulatory Affairs Team will provide guidance to you with  the target of choosing the right countries and sites for your project. National differences in local legislation or differences in national health systems are the key basis for selecting the right countries and sites for your trial. AMS, with its capabilities across Europe and with its global partners will close collaborate with you, based on feasibility results to select the right countries and sites for your project. The right country and site selection is an essential factor for later recruitment timelines and like this a key deciding factor on your project timelines, data quality and budgets. Benefit from our experience.
  • Setup

    Setup Realize your trial concept the right way We make sure, your trial set-up is time- and cost efficient and suitable to deliver the right data at the right time.     Starting with protocol set-up your AMS project team will guide you through the process of project set-up with high quality standards but also with continuous guidance to set-up the right project structures. We will proactively take care, your project is focused on its targets, being fully compliant to legal requirement but also innovative to allow cost and time efficiency.  
  • Clinical Setup

    Setup World Class Development Give your team the right clinical structures. Your AMS Project Manager will closely and proactively collaborate with you to find individual solutions for all operational aspects. As early as possible, your AMS Project Manager will start, in collaboration with you and your team to set-up the project team and establish processes, based on highly developed AMS-Standards, but also individually adapted to your project. We will guide you through all requirements of project set-up and provide a robust time-planning for all associated tasks required until start of patient enrolment.Your AMS Project Manager will be your primary channel of communication and interact with the involved functional groups and service areas within AMS and at your side.Based on the final country – and site selection, your pan-European AMS Clinical Operations Team, will take care of site qualification, site contract administration, Trial Master File Set-up, supplies management, essential documents compilation, arrange for site release and finally perform the site initiation. With its global partners AMS provide expanded possibilities for trans-continental projects. AMS will closely collaborate with its approved vendors, such as central labs, IMP-providers, translators and printers and coordinate all aspects of clinical set-up.  
  • Conduct

    Conduct Enjoy the difference of having a proactive partner Your cross-departmental AMS – team will proactively act as your partner through the conduction of your trial. By a robust and realistic planning of clinical tasks, we make sure your trial is on track and achieves its goals. Headed by the AMS Project Manager, a cross-departmental team of clinical research specialists will be your partner for an “in time” project conduction. From trial initiation to site closure, you will have real time access to your project status by innovative AMS-tools. Detailed task planning allows early detection of potential issues and your AMS team will early and proactively have solutions at hand. AMS uses state of the art clinical research techniques to fulfill both, the collection of high quality data by cost efficient processes, such as Risk-Based Monitoring or BYOD ePRO data collection.  
  • Reporting

    Reporting Reach your targets Your AMS project team will be prepared to guide you during the data cleaning process, keeping timelines by close proactive interaction. As soon as your trial reaches the data cleaning phase, your AMS team will have proactively planned the associated tasks to reach database closure in time. For this purpose the AMS Project Manager will closely interact with the CRAs, the Biostatistician, the Data Managers, the Medical Writers and certainly keeping you closely informed. Upon database closure, AMS Biostatisticians and Medical Writings closely collaborate for a timely provision of your Clinical Trial Report and associated publications or manuscripts.  
  • Clinical insourcing

    Clinical Insourcing Be flexible with AMS Insourcing Insourcing needs can arise by individual staff shortage at your department or by the operational concept. AMS will be able to support your team for both. AMS provides flexible and short term staffing solutions to support your team in-house by trained clinical research specialists. Please approach us, if AMS can support you by insourcing support, for your in-house tasks. Insourcing by AMS is offered as well full-time but also as part-time support. AMS is able to provide trained specialists, e.g. Clinical Research AssociatesClinical Trial AssistantsProject Managers Drug Safety Medical Experts, including (EUQPPV-function)Drug Safety SpecialistsBiostatisticiansMedical WritersRegulatory Affairs ManagersData Managers  
  • Strategic insourcing

    Clinical Insourcing Smart sourcing solutions, by AMS Instead of sourcing out tasks to a CRO-provider, you may wish to perform certain tasks in-house, using an external service provider for staffing. We consult you, where this may be the more efficient or effective solution and how sourcing by AMS can facilitate your research planning. While insourcing was formerly a service for short-term, strategic sourcing solutions have become a trend. Other than by recruiters, AMS provides fully trained and fully qualified clinical research specialists. Usually AMS has worked with these specialists and like this is ideally able to find the qualified, ideal, cost efficient and flexible staffing solution. For this purpose we offer    •    Clinical Trial Assistants    •    Clinical Research Associates    •    Clinical Project Managers    •    Other functions of individual request  
  • Full Services

    Services Standing out from the crowd AMS Clinical Research services cover the full range of service requirements for exploring and evaluating the benefit and the potential risk of new drugs through the different phases of clinical development. The increasing complexity of clinical trials calls for service teams who are able to bring more to the team, than just “a pair of hands”. The AMS management has remained focused on creating teams of staff who are constantly striving to improve their performances and deliver above expectations for our clients.   The performance of our globally experienced Project Leaders, remaining with your study throughout its life cycle: • Early development, incl. pivotal studies• Late stage clinical trials• Full service or individual niche services• Multi-national or local• Post-authorization strategies, e.g. NIS PASS• Trusted partners in ancillary services• Data Monitoring Committees   Overview on some therapeutic indications among others Neurology   Oncology   Immunology • Alzheimer’s disease   • Lymphoma & leukemia   • Multiple sclerosis • Cerebrovascular disease   • Multiple myeloma   • Rheumatoid arthritis • Degenerative dementia   • Skin cancer/melanoma   • Transplantation of liver, lung, kidney • Depression   • Bladder carcinoma   • Bronchial asthma • Diabetic peripheral neuropathy   • Breast cancer   • Psoriasis • Central neuropathic pain   • Colon cancer   • Dermatitis • Migraine   • Lung cancer   • Actinic keratosis • Parkinson’s disease   • Pancreatic cancer   • Encephalitis     • Prostate cancer   • Pollen allergy     • Glioma         • Cervical cancer    
  • Product Categories

    Categories Experience in all categories – the best start to enter new market areas in a safe and effective method. From conformity assessment to marketing. The close cooperation of our competence centers saves you time and money. Benefit from our long-standing AMNOG experience and our in-depth knowledge of reimbursement issues for medical devices. With our marketing & sales services, place your medical device on the market in the best possible way.   Providing success from premarket to sales:   Whatever you need, our performance meets your requirements in each of our specified product categories: • Medical Expertise • Monitoring & Project Management • Biometrics • Data Management • Data Entry • Drug Safety • Medical Writing • Quality Assurance & Audit •  Regulatory Affairs & Registration • Training & Education