Clinical

Argint's clinical group consist of a large team of experienced project managers and CRAs, all with medical, pharmacy and life science degrees.    

Our team provide support for clients throughout all stages of the development cycle, from initial feasibility and consultancy advice on study design, through phase I, POC and larger phase II and III studies.

Consultancy

Argint regularly works with clients who are in the early stages of planning their development program of clinical studies.  We are happy to help clients design studies that are possible to execute, maximise the chances of obtaining a clear result, and minimising cost. 

Our connections with key investigators and therapeutic experts enable us to provide invaluable feedback to clients as they develop their protocols.

Argint also provides statistical advice through our expert partners who are also experienced in adaptive study design.

Feasibility

Site selection is critical to the success of any study.  As part of any proposal in response to an RFP we provide commentary on the proposed study design and a detailed study plan to deliver the study within the required timeframe.  Our study plans are based on feasibility conducted by senior clinical professionals who engage in detailed telephone discussions with investigators and face-to-face meetings with KOLs.  Our study plans are accurate and reliable and we stand by our promises contractually.

Project Management

Argint's project managers provide a single point of contact to our clients.  They are able to assume responsibility for managing as much a study as the client desires, including management of service delivery from multiple vendors as part of a full service solution. 

Argint's project managers are responsible for, and committed to, ensuring studies finish on time and within budget.

Monitoring

Argint has a rigorous process for selecting the best candidates for the monitoring role.  We have an extensive training program for our CRAs.  Argint are the exclusive training partner of Brookwood International Academy  and all of our CRAs must complete and pass the Brookwood training courses:

  • Fundamentals of Clinical Research & GCP
  • Foundation Course in Clinical Research (Certificate in Clinical Research & GCP, Part 1: basic)
  • Advanced Course in Clinical Research (Certificate in Clinical Research & GCP, Part 2)

All of the courses have been awarded continuous professional development points (CPD) by the Faculty of Pharmaceutical Medicines of the Royal Colleges of Physicians of the United Kingdom.

In addition to the set classroom courses, every Argint CRA has a detailed training and development plan which includes multiple on-site training visits by Argint's training manager and senior clinical personnel.

Our CRAs are fully equipped to ensure that all aspects of the protocol and ICH GCP are followed by investigators.  They help ensure the safety of participating patients and the integrity of the data received by the sponsor. 

Sites managed by Argint CRAs have been inspected by the FDA on 3 occasions and by local European Competent Authorities on numerous occasions.  The outcome: no action indicated.

Phase I

At the beginning of 2005 the Clinical Pharmacology Unit (CPU) of the 1st Dept. of Internal Medicine, Semmelweis University, was accredited by National Institute of Pharmacy ( the Competent Authority in Hungary).  The accreditation was renewed in 2008 and again in April 2012.  In December 2011 Argint entered into a partnership agreement with Semmelweis University to develop and co-market the CPU as Argint-Semmelweis CPU.  The partnership with Argint resulted in significant inward investment in new infrastructure and updated equipment.

Argint-Semmelweis CPU consists of 12 beds in 3 air-conditioned rooms, with 3 bathrooms. The unit is separated from the general hospital by means of a restricted access door (swipe cards). The unit has camera surveillance and a member of staff is present 24 hours per day when a study is taking place and volunteers are present in the unit.  The CPU is located within 50 metres of the Intensive Care Unit for the hospital, and 100 metres of the dialysis unit.  The Central Laboratory for Semmelweis Univeristy is an accredited laboratory and is located in the same building as the CPU.

Argint-Semmelweis CPU offers the ability to perform phase I, bioequivalence drug-drug interaction and drug-food interaction studies in a modern, accredited, phase I unit located within the 1st department of Internal Medicine, Semmelweis University, Budapest, Hungary.

In addition to studies in healthy volunteers, the unit conducts phase I studies on specialized patient populations. During such studies a specialist in the particular therapeutic area joins the CPU team to ensure the necessary skills are available for specialist assessments and patient care. As Semmelweis University Hospital treats patients with all medical conditions there are always specialists available to support any specific indication – even in the case of rare diseases.

IT: Collaborative Study Platforms

When Argint has responsibility for project management of a study we create https-secured extranet collaborative platforms.  Access is granted to all Argint staff, partner CROs, sponsors and specialist vendors / laboratories.

Platforms allow:

  • sharing of core study documentation/SOPs
  • patient recruitment data, status reports, project plans
  • study news
  • effective ‘change control’ throughout the study

The infrastructure for the platform is provided by a world recognized IT provider that is both Microsoft Gold and ISO:27001 accredited.  The servers are securely located in a tier 4 data centre in the City of London.

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