Quality Assurance

BECAUSE IT HAS TO BE RIGHT

Highly developed quality systems - effective whilst not restrictive.

  • Effectiveness of the QA system is confirmed by external audit metrics. From October 2015 to the current date we have received 6 Sponsor Audits, all of which have returned only minor findings. The last MHRA audit in September 2016 reported no critical or major findings.                                                                  

  • Efficiency is demonstrated by the speed at which we deal with quality issues from any source that may arise, by root cause analysis and corrective and preventative action (CAPA).

 

  • MAC has around 100 SOPs and policies, to which every MAC site works closely. These cover both early and late phase operations.  Adherence to authorised procedures across sites is regularly audited via study-focused and system audits.  Document control is managed centrally, extending from SOPs to key study-related or supporting documents and company policies. Procedures can be revised quickly, without the onerous process sometimes encountered in some of the larger organisations.

 

  • The QA department has an independent position within MAC, as illustrated below:

  • The QA department have 30+ years’ of experience and work actively with operational management to provide quality solutions for the whole business. This has proved a rewarding partnership. The Head of QA and QA Manager are regularly involved with the RQA (Research Quality Association) in training and networking initiatives. Auditing is strongly supported by advice and facilitation, adding considerable value to the process.

  • External audits by regulators or sponsors are managed closely by the QA department.  Sponsor audits are not uncommon, since MAC is often targeted as the top recruiter, but these are routinely dealt with and usually return no significant findings.

  • Staff are regularly trained and coached on critical areas requiring quality compliance.  GCP training is also conducted periodically on all staff.

  • Customer feedback is obtained from Sponsors, Monitors and Patients, then trended and shared with senior managers. Mean satisfaction scores from all sources are currently running at better than 90%. 

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