Services

WHAT WE DO

CLINICAL PROJECT MANAGEMENT


It is critical to set the project on the right path from the start. Before we embark on a challenging journey we make the necessary preparations, meticulously map the path and plan for success. AnRes as your partner in clinical development will support you in reaching the ambitious goal.  

We run projects starting from drafting a study protocol which is evaluated by a medic and a statistician. This step is immediately followed by careful planning and creation of project management tools.

Our experienced team will guide you through all the stages of your project.

We provide coordination and integration of all the clinical study activities as well as efficient project communication among all the parties involved. Project managers are in charge not only of project progress evaluation but also responsible for clinical monitoring oversight and risk management.



 

 

VENDOR OVERSIGHT - ASSISTING SPONSORS IN THEIR OVERSIGHT RESPONSIBILITIES

We have hands-on experience of overseeing sponsor´s vendors including Clinical Research Orgnanisations, Central Laboratories and IMP depots. While trust and collaborative approach is key, we ensure that the expected quality is ensured and appropriate metrics met. 

We perform risk assessment and provide effective issue resolution. 

We are promoting a quality mindset among the client's collaborators.  

CLINICAL MONITORING & REGULATORY SUBMISSIONS


Clinical monitoring is about ensuring patient safety and clinical data integrity. Our CRAs understand the study objectives which means they focus the data that really matters. 

We ensure that CRAs channel all effort to process excellence, understanding the intricate issues of the protocol and indication (disease), ensuring site compliance, risk mitigation, and building strong site staff relationships.

We believe focusing on those areas are the basis to outstanding clinical monitoring service.  


  • EARLY PHASE STUDIES

    For many years we have been involved in phase 1 and phase 1/2 studies executed at Phase 1 units or Investigator sites. Typically, a medicinal product is administered to volunteers for the first time according to the Single Ascending Dose (SAD) design and Multiple Ascending Dose (MAD) design.

    We provide on-going safety monitoring performed by Medical Consultants, who are a part of the Safety Review Committee together with the involved Investigators. Our experience specifically includes healthy volunteers studies and early-phase trials to establish the dose of a study drug in oncological and rare diseases both in adults and children.

  • Our team members worked in all stages of clinical development. One of our expertise areas is Real World Evidence.
  • We have extensive retrospective studies, natural history studies, prospective research including Patient Reported Outcomes and patient surveys. Together with our Data solution partners we can develop the needed Patient Reported Outcome tools. 
  • We can currently provide freelance high-quality clinical monitoring services in Denmark, Sweden, the UK, Spain, Italy, Poland, France, the Netherlands and the US. All of our CRAs are senior, can fully support a clinical trial in their respective country and have been tried and tested in past collaboration.
  • This is list is continually growing. 

OTHER SERVICES

REGULATORY AFFAIRS


  • Clinical Trial Submissions (CTA, IND)
  • Labelling of clinical trial materials
  • Regulations and guidelines governing clinical trials
  • EU VHP submissions


DATA MANAGEMENT SOLUTIONS & STATISTICS

  • CRF design, development and hosting
  • Patient eDiary, Patient eQuestionnaire design and development
  • Data import and processing
  • Statistical analysis 


PHARMACO-VIGILANCE


    • Pharmacovigilance System  development
    • Full-scale processing of Individual Case Safety Reports (ICSRs);
    • Safety surveillance and signal detection 
    • Development DSURs PBRERs
    • National regulatory intelligence


SITE CONTRACT MANAGEMENT


Fully outsourced, end to end, site contract management solution (inclusive of budget and contract language) within EMEA and APAC.

A disruptive, pragmatic and result oriented and a client centred approach. Ultimately providing the clinical sponsor the necessary depth of advice and expertise that large CROs are failing to deliver.

CONTACT US NOW TO SEE HOW WE CAN SUPPORT YOUR PROJECT


Contact Info

Banegårdspladsen 1A, Vejle, 7100, Denmark

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