What We Do
We have extensive experience across all aspects of GCP quality support:
Quality Management
We are experts in QMS development, management and optimisation, whether starting with an established system or building one from scratch.
We facilitate process mapping sessions with relevant teams, helping to focus discussions and using electronic tools to map in real time. We can use the resulting process maps to develop SOPs and other controlled documents. We can also offer advanced process maps that could replace the need for written SOPs if your organisation wishes to streamline.
We can set up a procedure for management of your deviations, non-compliances, quality issues and CAPA, or assess and process these using your existing procedures.
We can assess potential serious breaches, liaising with the relevant people within your organisation, and assist you with reporting these in line with regulatory requirements.
We can help with eQMS system selection & validation advice, taking your specific requirements into account and helping to ensure the selected eQMS fits your needs.
We can analyse, plan and execute QMS transitions after acquisitions and mergers. This is often a complex and sensitive process, and our experience with such transitions allows us to approach this in a measured and diplomatic way.
GCP Consulting
We are able to offer operational quality advice and process development services related (but not limited) to all of the following:
Vendor selection & oversight - this important aspect of GCP may seem daunting but we can guide you through this and make it an integral part of your operation. We can also assist with selection and oversight of specific vendors you wish to work with.
Risk assessment & management - this subject is another that may seem complicated and full of jargon; we can break down the requirements and develop a process that is fit for your purposes. We are also able to assist with performing GCP risk assessments on a study level, for vendors, for audits, and for other areas of your operation.
Computer System Validation - we can guide you through the requirements and assist your operational teams and IT department through the validation process.
Decentralised trials - we have considerable experience with different decentralised trial services and can advise on selection, risk assessment and deployment of these.
Archiving (electronic & paper) - we have substantial experience in GCP archiving and can assist with all aspects of this.
Clinical trial monitoring advice - we are able to help you plan the monitoring strategy for your trial, taking the risks of the trial and the sites into account.
Inspection Readiness - we can help your organisation assess your ongoing inspection readiness, or help you to prepare for an inspection that has been announced.
GCP Auditing
We have extensive experience in performing a wide-range of GCP audits, and in developing and delivering GCP audit programmes.
We work with you to target the audit scope to your needs. We believe that audits should bring value to the sponsor and to the organisation and individuals being audited; we do not believe that audits are a tick-box exercise or that 'one size fits all'.
In addition to offering these targeted audits which focus on specific areas and topics, we also recognise the value of performing holistic quality reviews of projects. These are approached slightly differently, where we look at the study or project as a whole and aim to identify not only issues, but areas for improvement, best practices, and previously unidentified risks that have not yet manifested into issues. This empowers you as sponsor to take action and avoid problems further down the line, and to share best practices across your organisation.
We have experienced audits from "both sides of the table", and this helps us to secure the maximum value from an audit for you.
We perform:
- Study audits, including:
- TMF
- Holistic
- Site-specific
- Process/system audits
- CRO audits (full service or individual services)
- GCLP laboratory audits
- Vendor audits
GCP Training
We believe in GCP training that fully equips your staff to perform their roles with confidence.
We provide bespoke GCP training tailored to each functional area, helping individuals to understand how the principles apply to their role and everyday tasks.
We also provide focused training on specific GCP topics, either as initial training or as refreshers.
We can develop training based on your organisation's policies and procedures, bringing them to life and helping with compliance.
We can provide bitesize training for continuous learning, helping people to quickly remind themselves of pertinent points at the right time.
We can assist you with development of training matrices applicable to the various roles in your organisation, to improve clarity and visibility of required training across roles.
Training may be provided live (via video conferencing or in person), on-demand (recordings, eLearning), or as a package that mixes both. We endeavour to include elements that improve and assess the trainees' understanding, including quizzes, workshops, breakout groups, case studies, and more.
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