Feasibility Services

Broad Laboratory management

Doyou have a specific clinical or microbiological laboratory part in a Study Protocol? Or would you like to select an ideallaboratory for to perform all necessary laboratory tests?

CLAUSE….

  • Makes selection of laboratory according to the Study Protocol or any other specific requirements.
  • Performs the GCP training for all personnel of laboratories
  • develops laboratory manuals, specific forms,
  • performs supply of necessary materials to the laboratory,
  • makes transportation of laboratory samples from clinical site to laboratory in time and temperature regimen
  • performs regular quality control of the laboratory during the whole period of the clinical study.

We are the main link between your clinical site and laboratory during 24 hours per day

What is a Thorough Quality Assurance? It is CLAUSE.

Quality control is one of the main key to guarantee the data are high qualitative and reliable. We have the key, we know the password” Quality control is one of the main key to guarantee the data are high qualitative and reliable. All team members are trained on GCP, applicable SOPs and protocol-specific requirements prior and during conducting clinical trials activities. Training on GCP and SOPs are performed on a regular basis for the entire staff. Thus, we ensure that all procedures are under strict control.

Quality Assurance

  • Internal quality assurance
  • External site, study audits
  • Guidance for the client towards optimization of quality assurance and controlling systems
  • Preparation for audits and inspections
  • Project audits, e.g. investigator files audits, trial master file audits, clinical study report audits and regulatory submission audits
  • Implementation of corrective and preventive action plans (CAPA) and help to improve performance

Please feel free to contact us anytime for more information!

What is precise Clinical monitoring? It is CLAUSE.

All our monitors have either medical, or pharm or biological education. Each year all our CRAs receive the ICH GCP training. For each clinical Study we build the team of clinical monitors, basing on their specific experience in the concert therapeutic area. We believe that CRA is the key to get qualitative data in the Study. With CLAUSE your trial will be under the strict monitoring to receive the high quality data.

What is a Comprehensive Project Management. It is CLAUSE

We consider a Project manager to be one of the main person who controls the whole Study process and is the main link between Clinical Sites and Sponsor. In CLAUSE there is a close cooperation between all our team members in order to provide our Client with quick response at any request. We are always focused on quality control to achieve the highest results in every step, in everything we do! We guarantee the result. We guarantee the terms.

Please feel free to contact us anytime for more information!

What is a Reliable Regulatory support? It is CLAUSE

Which country is the best to organize your clinical trial? How long does it take to get approval? Which traps and pitfalls are there? Regulatory environment in each EU country differs. We provide you with the detailed information about regulatory environment of the country you may be interested in. We help you to prepare the Dossier and will support you at every step to get the approval. We focus on result.

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