• Clinical Trial Authorisations
• Pharmacovigilance
• Clinical Report Writing
• GCP Audits

A wealth of expertise in clinical research exists within Wainwright Associates. Specialists in the design and conduct of clinical trials offer their consultancy skills advising on clinical and regulatory strategy for new product development, design of clinical trial protocols and preparation of applications for Clinical Trial Authorisations.

GCP Audits of investigational sites and CROs can be undertaken by our staff. We can also handle your pharmacovigilance, both pre- and post-marketing, including reporting to the appropriate European Competent Authorities.

Clinical consultancy, including development of clinical reports, is also available in the context of applications for Orphan Medicinal Product Designation, Scientific Advice and Marketing Authorisations, including appeals and oral explanations.

Clinical Trial Authorisations

Under the Clinical Trial Directive 2001/20, authorisation by a Competent Authority is required to conduct trials on human volunteers or patients in any EU member state.

The procedure involves applying to the EMEA for a EudraCT number and then submitting an application for Clinical Trial Authorisation (CTA) to the Competent Authority of each member state where the trial will be conducted.

Wainwright Associates can advise on the requirements for and prepare the necessary documents that constitute the CTA as well as handle communications between the authorities and sponsor or legal representative.

The specific data requirements for the CTA differ between member states and we can assemble a core document and customise it for specific authorities, including translating any documents that may be needed locally.

CTA preparation involves the detailed assessment, by discipline specialists, of the component parts, such as the Investigational Medicinal Product Dossier (IMPD), Investigators’ Brochure and protocol. In this way any weaknesses or omissions in the data can be identified and resolved, possibly avoiding unnecessary questions or a rejection from the Competent Authority.

Post-approval, we can maintain your CTAs by submitting variations for any changes to the protocol and notify the Competent Authority of study completion.

Pharmacovigilance

Pharmacovigilance is an ongoing requirement for marketed medicines and for those under clinical investigation. Wainwright Associates offers a range of services in connection with pharmacovigilance.

During clinical research, we can write or review SAE narratives and report SUSARS to national regulatory authorities and ethics committees together with their electronic reporting onto the EudraVigilance database.

Furthermore, we produce safety reviews for clinical reports or investigator brochures and quarterly/annual safety reports.

Our post-marketing services encompass the above and also include pharmacovigilance planning, writing and review of periodic safety update reports (PSURs) in addition to conducting post-marketing surveillance studies or literature reviews.

Our team of clinical consultants and medical advisors will liaise with the Sponsor and CRO to expedite matters and can act as a named Qualified Person for pharmacovigilance if required.

Clincal Report Writing

Once the trial is completed, if required, we will be happy to write the clinical study report. We can do this by liaison with your clinical and statistical departments or responsible CRO in provision of trial information and data.

Once the report is in a late draft, we will work with your clinical department , auditors and investigators on reviewing and updating the document.

GCP Audits

Sponsors need to satisfy themselves that a CRO is capable of conducting a clinical trial to the appropriate standards and that it has the appropriate GCP quality systems in place.

Once the study has started, the sponsor needs to know that the investigational site is GCP compliant, is following the protocol and is being adequately monitored by the CRO.

Wainwright Associates offer GCP auditing services in both the above situations

Our auditors are experienced in both clinical research and regulatory affairs and, at an early stage, can advise on any matters requiring attention and discuss solutions

Audits commence with a review of the study documentation, such as SOPs, protocol and training manuals being done either in house or at the company site. After the required time on-site, including interviews with the relevant personnel, a detailed report of our findings will be issued.

We can also conduct data management audits by on site interviews and review of study documentation.