Clinical Trial Regulatory.
How Arriello can support your Clinical Trial Regulatory needs.
Arriello provides a wide range of services and solutions to support clinical trial and Investigational New Drug Applications (CTAs & INDs) globally. Whether your company is planning an FDA Pre-IND Meeting, or preparing for a study (phase 1-4) in the UK, or an EU multi-national pivotal clinical trial, our team can support with the following:
- Trial design.
- Agency meetings and liaison.
- Country submission strategy.
- Document preparation – e.g., protocols, investigator brochures, IMPDs, IND module documentation and patient documentation such as patient information and consent forms.
- Coordination and tracking of country submissions and translations.
- Drafting/review of responses to agency questions.
- Provision of local expertise that is essential to ensuring all requirements are met.
- Advice on classification, preparation and submission of amendments and annual reporting requirements.
- Document redaction.
- Database updates (EU Clinical Trials Register & ClinicalTrials.gov).
EU Clinical Trial Regulation & Submissions via CTIS.
The new Clinical Trial Regulation (CTR) became mandatory as of 31st January 2023 for all new studies in the European Union. This important regulation enables sponsors or their designees to submit all regulatory and ethics documents via a single online platform (CTIS) to achieve a harmonized review across the EU Member States.
Some studies are still ongoing under the Clinical Trials Directive 2001/20/EC and, if the studies are expected to continue beyond 31 Jan 2025, they will need to be transitioned to the CTR. We recommend that transitioning of clinical studies is initiated as early as possible in 2024 as there could be large number of studies submitted for review, which might result in extended approval times. Contact us if you would like support with the transitioning of your clinical study to CTR: firstname.lastname@example.org
Our team are on hand to provide support ranging from ad hoc questions related to set-up in the system to full regulatory management and submissions via CTIS.
In August 2022 Arriello commissioned a survey to gauge US/UK/EU experiences and opinions of using CTIS so far and you can read the survey results here.
UK Combined Review Submissions.
Following its withdrawal from the EU, the UK has designed and implemented a clinical trial review system that is competitive with the EU Clinical Trial Regulation (CTR). The UK combined review is a single submission submitted through a portal for both regulatory and ethics review.
The reviewing bodies remain the MHRA and RECs that were already in place pre-brexit. After both have reviewed their respective sections of the application, approvals are issued within 60 days. The UK also has the option for a fast-track review for both healthy volunteer studies and some multi-country studies. The system has been mandatory since January 2022.
Our experience to date has been very positive and we are seeing the UK remain one of the fastest countries for study start up in Europe.
US IND Submissions.
For many companies, opening a US IND is seen as a huge milestone in the development of their product and a success that is often announced to financial markets.
Alongside the usual CTA services, our team in the US can support you with the important FDA pre-IND meetings/interactions, US agent services and of course the eCTD publishing and submission through the FDA gateway.
Rest of World CTA Submissions.
Our expertise with clinical trial submissions extends well beyond Europe and the US, with local teams to ready to support globally.
Initial approval of a clinical trial is only the beginning! Thereafter the CTAs/IND need maintaining. Our team will coordinate, submit and track the following submissions/notifications as required:
- Public registry submissions and updates (e.g., ClinicalTrials.gov).
- Substantial amendments/modifications.
- IND protocol and information amendments.
- Temporary halt notifications.
- End of study notifications.
- Study results submissions including lay summaries.
- Serious Breach of GCP notifications.
CRO Oversight Services.
In addition to our clinical trials submission services, we also offer oversight of clinical trial application submissions being managed by one or more CROs. This is a particularity useful service for our SME clients, where there may not be an in-house regulatory professional or where there is not adequate resource or experience within the current team.
It enables the sponsor to maintain important regulatory oversight, ensuring the submission strategy is aligned with the sponsor’s corporate goals and consistent messaging is being communicated to health authorities. It also provides CROs with a ‘point person’ who speaks the same “regulatory” language, whilst being able to translate and discuss any regulatory challenges internally with your team.
What our clients say about us.
Arriello has highly knowledgeable staff in all countries with a very professional attitude. They are very fast in responding when needed.
My experience with Arriello was an overwhelmingly positive one. Very professional, accommodating and readily able to adapt to our needs even as they changed.
I’d like to personally thank you for the high quality of Regulatory support you’ve given us so far, especially Gabi and Maria and your local partners. We’re very satisfied with the service.