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QA-Services general

Contract Research Organisations Audits
  • Outsourcing is a common topic within clinical research. We can help you assessing the overall compliance status of Contract Research Organisations tailored to you specific needs and the services you are planning to outsource. We have experience in auditing specific services as e.g. Data Management and Biostatistics in applicable detail

Data Management and Biostatistics Systems Audits

  • We have experience in Data Management and Biostatistics audits. This is true for specialised service providers as well as internal organisations within big pharmaceutical companies. Common topics can include the handling of data in line with current data standards as CDASH, SDTM and ADaM

Internal System Audit Programs

  • We can provide you with either support in running your internal audit program within your company or we can come in as external independent organization to provide you with our independent expertise to perform internal systems audits and to facilitate your quality improvement initiatives

Mock Regulatory Inspections

  • We can run systems audits as Mock Regulatory Inspections to show you where your organizations’ gaps are and to train your staff on the overall “dos” and “don’ts” to perform as self-confident and efficient as possible to achieve the best possible inspection results

Trial Master File Audits

  • We can perform Trial Master File audits to assure that the filed documents are complete in line with regulatory requirements and supporting the Regulators’ Expectations to support the reconstruction of all trial activities

Investigator Site Audits

  • We can perform Investigator Site Audits based on experiences in various countries and different therapeutic areas. We can support you in running your regular Investigator Site audit programs and to manage short term peak QA resource demands

Documents

  • We can support you in auditing your essential study documents (e.g. protocols, Clinical Study Reports) to ensure that these documents are compliant with applicable regulatory requirements

Gap Analyses

  • We can perform Gap Analyses for existing Qualification/Validation frameworks and develop remediation plans to resolve deficiencies. We can support organisations in the Development of missing SOPs and templates as needed

Quality Management Systems (QMS) Development

  • We have experience in the development of QMSs under GCP. This is true for frameworks covering the performance and operation of clinical trials as well as processes and procedures to run a compliant IT environment to support these activities

Regulatory Inspection Support

  • We can support you during regulatory inspections in sitting in during interviews supporting answering questions and giving strategic feedback to the interviewees. We can support you in the back office assuring that appropriate documents are provided as requested

Training

  • We can provide cost-effective GCP related or IT regulatory trainings tailored to your specific needs with regard to specific content and time. From Inspection Preparation trainings to training organisations in the usage of common validation technologies and frameworks to put them into the position to create their own company specific validation process workflows