Advantages of Niche Providers for Regulatory Affairs

Have you considered the advantages of a niche provider with the reassurance of specialist regulatory expertise to deliver your Clinical Trial Authorisation (CTA) alongside your Clinical Research Organisation (CRO)?

With an increased emphasis on quality control, specialised providers now have a demonstrable track record for delivering regulatory approvals whilst your CRO focuses their expertise on clinical trial management.

Outsourcing

When clinical trials are outsourced to third parties, regulatory expertise and local knowledge often resides within the clinical trial CRO rather than with the sponsor. This may make it difficult for the Sponsor to adequately assess the clinical trial CRO’s performance and ensure sponsor oversight. The added value in creating an alliance with a niche provider of regulatory services lies in the country specific support provided to the Sponsor resulting in consistent and locally compliant CTA submissions and processes to provide evidence of sponsor oversight.

Sponsor Oversight

Sponsor oversight is a key part of Good Clinical Practice (GCP) and inspections from national agencies will look for evidence of this oversight in all areas including regulatory submissions. Documentation associated with QC (Quality Control) of regulatory submissions which shows the Sponsor has reviewed and agreed with the submission can provide such evidence. A QC procedure can ensure that all local regulatory offices provide consistent and high quality information on the trial to regulatory authorities. In addition a QC procedure can ensure that the sponsor is aware of all submissions made on their behalf and can file a complete record of all submission documentation. Regulatory sign off and following regulatory procedures for the “green light” process can also provide evidence of adequate Sponsor oversight in this important area.

Niche Provider

Real Regulatory is a niche regulatory provider with experience in the preparation of clinical trial applications for multinational clinical trials. Real Regulatory have internal regulatory procedures which can be applied to your CTA process and access to local country specific expertise to ensure the best quality submission. Real Regulatory can work in partnership with your clinical CRO to give the best possible chance of regulatory success.

Real Regulatory aims to build long term relationships with Sponsors by integrating into your project team as and when required, for peak periods of regulatory activity. This flexibility ensures you have product knowledge without maintaining internal overheads.

Real Regulatory can prepare a project specific regulatory management plan to clarify regulatory roles and responsibilities, communication processes and QC of submission packages. Real Regulatory can also prepare and manage tracking tools for submission documents and translations to ensure that regulatory hurdles are anticipated and approval timeline expectations are managed.
To download full article, click here (published by www.samedanltd.com).


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