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Our Services

Based on our knowledge, experience and competence, the ZAK team has all necessary skills to support your company in the following fields to successfully execute your medical device or drug development program.

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Clinical Operations

Based on our extensive therapeutic expertise and well-established relations with clinial experts we are confident to manage proper planning, execution and completion of all projects trusted to us.

  • patient recruitment – tailored recruitment strategies as a critical success factor to identify the right patients for your clinical trial
  • patient retention and site productivity – key strategies to retain patients in order to ensure successful completion of clinical studies
  • regulatory authorisation – professional cooperation with Ethics Committees and Competent Authority as backbone of successful clinical trials
  • clinical monitoring and site management – comprehensive clinical monitoring services from feasibility to study close-out
  • project management – ensure that deliverables are met within the proposal and on timely manner
ingrid_hochmayer

Contact Person

Ingrid Hochmayer, M.Sc.

Managing Director/International Head of Clinical Operations

i.hochmayer@zak-services.com

+43-1-879-38-95

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„Each project starts with a detailed analysis of the feasibility and a clear target agreement. This is one of the most important prerequisites for the success of a study."
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Regulatory & LIFE-CYCLE MANAGEMENT

Our regulatory affairs specialists have years of experience working with regulatory agencies throughout the pharmaceutical, biotechnology and medical device registration process.

Once a product  is on the market we provide support in maintaining the marketing authorisation during its life-cycle.

  • review of Common Technical Document (CTD)
  • determination of regulatory status and consulting services
  • pre-submission review of documentation
  • national marketing authorisations
georg_franz

Contact Person

Georg Franz, M.Sc.

Regulatory Affairs Manager

g.franz@zak-services.com

+43-1-879-38-95

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"Every challenge is a step to further improvement."
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Medical Writing

In regards to our extensive experience in clinical research and drug approval procedures ZAK developed relevant expertise in medical writing and preparation of essential documents.

Our services include medical writing in the field of regulatory affairs, clinical research and pharmacovigilance:

  • pre-clinical & clinical surveys
  • Summary of Product Characteristics
  • subject information & informed consent forms
  • study protocol & synopsis
  • final study report
  • poster presentation
  • patient safety narratives
  • pharmacovigilance documents (e.g. Periodic Safety Update Reports)
  • translation services
barbara_haas

Contact Person

Barbara Haas, M.Sc.

Clinical Research Associate (in-house)

b.haas@zak-services.com

+43-1-879-38-95

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“Bringing together and presenting information and data in a way that everyone involved knows what we're talking about."
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Quality Assurance

ZAK is commited to deliver quality, regulatory compliant clinical research services in a professional, cost-effective and efficient manner while protecting the patient safety and data integrity. Our services include:

  • independent quality assurance services
  • pre-audit inspection and support of investigational sites
  • GCP auditing (compliance & system audits)
  • quality management consulting (GCP compliance, support in inspection readiness programs, consulting for implementation of QMS according to ISO-9001)
  • SOP review and writing
  • consulting services
  • process improvement

barbara_markhardt

Contact Person

Barbara Markhardt, M.Sc.

Quality Assurance/Clinical Trial Regulatory Specialist

b.markhardt@zak-services.com

+43-1-879-38-95

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"Ensuring the implementation of a Quality Management System as a prerequisite for successful clinical trials and development of new theapies."
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Network

Our mission is to enhance the quality of trials by partnering with contract research organizations/vendors and providing you with forward thinking, cost-effective methods through our performance driven professionals.

  • site management activities (SMO)
  • site referral network
  • global trial management
  • Phase-I unit network
peter_palagyi

Contact Person

Peter Palágyi, Pharm.D.

Head of Slovak Representation/Business Development/Vendor Manager

p.palagyi@zak-services.com

+421-536-30-258

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"Fully integrated clinical research networks around the world for those who rely on ZAK for their clinical research solutions."
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tailor-made Services

Over the years ZAK gained expertise which led to offering unique services which are tailored to the customers’ needs. In order to provide these services, each case is viewed individually.

  • clinical staffing solutions (e.g. in-sourcing of clinical research professionals)
  • training and learning services (GCP, regulatory affairs, medical training)
  • trials in rare diseases
patrizia_kahl-rainer

Contact Person

Patrizia Kahl-Rainer, D.Sc.

International Group Leader/Senior Project Manager

p.kahl-rainer@zak-services.com

+43-1-879-38-95

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"However difficult and challenging the requirements of a project may be, you will only succeed if you have enough self-confidence."