How does QA continue to add value in the changing world of clinical trial execution? Regulators worldwide are looking to industry to explain how they are managing risks to clinical trial quality. Wider Perspectives will work with you to:
We can assist you to choose the correct vendor for you. The selection of vendors should not stop at assuring regulatory compliance, but should also facilitate the foundation of an enduring and mutually successful business relationship. Having selected your vendor(s) how will you ensure that they deliver what you need? – We know the risks and we can help.
Wider Perspectives has successfully completed audit assignments encompassing vendor selection, in-process and for-cause investigations. Vendor types include full-service and niche clinical and biometrics CROs (including phase 1 units), IVRS/IWRS, ECG and e-CRF, central laboratory, clinical safety, packaging and labelling and regulatory service providers.
Geographic coverage includes North and South America, Europe and Asia Pacific.
Wider Perspectives has completed audit assignments across all phases of clinical research and in many varied therapeutic areas. Our experience covers pharmaceuticals, biopharmaceuticals, gene-therapy and medical devices. In geographic terms, our projects span Europe, North and South America, Africa and Asia Pacific (totalling well over 50 countries).
Our comprehensive service includes evaluation of study related documents (including protocols, Investigator Brochures and clinical study reports); clinical sites; laboratories; CROs; SMOs; eCRF and IXRS vendors; affiliate organizations; databases and statistical outputs; and regulatory submissions for European and US markets (MAA and NDA).
It’s not just about regulatory compliance!
In the context of your business, we will work with you and your team to audit your current systems and processes (and those of your vendors, where relevant) and to agree key actions to manage risk and achieve real quality improvement. Recent system audits have included safety management and risk-based monitoring processes.
We have supported many sponsor companies in preparing for, facilitating during and responding to inspections by a variety of regulatory agencies including MHRA, EMA and FDA. Our experience cover both pre-marketing authorisation inspections and statutory GCP inspections (Europe). We have conducted pre-inspection training at investigator sites, CRO vendors and at sponsor offices prior to regulatory inspections. These activities have included conducting inspection readiness training for staff, conducting mock interviews through to full-blown mock GCP inspections (including reporting and follow-up) to simulate FDA, EMA or MHRA inspection practices.
Both of the principals of the company have experience of undergoing GCP inspection in their previous roles prior to founding Wider Perspectives Limited and have participated in a variety of regulatory inspections since starting the company.
Since 2002 we have completed assignments to evaluate the business operations and capabilities of potential acquisition targets, helped to plan and execute the integration process and completed independent evaluations of potential strategic alliance partners. We have assessed the regulatory compliance of target company facilities systems & processes as well as identified potential integration issues.
The two principals have undertaken the training and mentoring of GCP auditors in South Korea, Japan, USA, South Africa, Finland and UK since 2010. Bev Brummitt was appointed tutor for the RQA Auditing course* in 2005, which due to its success and popularity runs three times per year. Since that time Bev has helped to train auditors from a wide variety of countries and organisations.
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