Support with quality assurance

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Apoio com a qualidade

Quality assurance

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Qualidade

Support with quality assurance

Good clinical practices in the context of the documentation produced in a clinical study are essential to ensure the integrity, completeness, reliability, and truthfulness of clinical research.

The support service with quality assurance ensures that the documents prepared throughout the clinical study meet the highest quality standards and streamlines the contractual process by providing templates of documents for download related to all clinical study activities, including participant recruitment, informed consent, data collection, and data management. Each template can be independently adapted or additional support can be requested from the PCS team for personalized completion. This service also includes the adaptation of existing documentation to align with good clinical practices.

By providing this service, the goal is to increase the efficiency of clinical study preparation and ensure compliance with good clinical practices.

If you need support with quality assurance, just click on request service.

What will you have access to when requesting this service?

To ensure your documents comply with quality standards, you will have access to the following information

Templates: Selection of standardised templates for downloading essential documents at all stages of the clinical study, facilitating organisation and compliance.

Documentation quality: Assurance of contractual or standard documentation in accordance with current quality criteria, ensuring integrity and reliability.

Personalized support: Personalized support in completing documents, promoting accuracy and alignment with the specific requirements of the clinical study.

Required documentation

In order to provide the Data Entry service, the following documents must be submitted:
  • Protocol or synopsis of the clinical study
  • Confidentiality agreements, if applicable
  • Templates of contractual documentation from the Sponsor/CRO or CRS, if applicable
Service benefits
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Quality Assurance
Documentation produced in accordance with with good clinical practices.
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Personalized support
Support in filling out the requested documentation, tailored to the clinical study and with quality assurance
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Variety of templates
Variety of documents to select from, allowing for more efficient conduction of the clinical study
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