One of RenaClinical’s first clients was a large research organisation based in Australia. The Client was running a clinical trial within Asia Pacific and wanted to expand into Europe. As this was the Client’s first foray into European clinical trials RenaClinical provided key regulatory advice to help the Client navigate through the complexities of European clinical trial regulations. RenaClinical was initially used as the Client’s EU QP release & distribution hub serving clinical trial sites in UK & Netherlands. To assist the Client’s recruitment targets additional clinical trial sites were established in Switzerland and RenaClinical provided additional regulatory advice for the Swiss CTA application process. RenaClinical has since supported further supply to Brazil and Nigeria on behalf of the Client.
During the study a number of supply chain issues have been successfully managed via close collaboration between RenaClinical & the Client. One of the main issues related to a shortage of comparator stock used in the study. The original supplier of the comparator had no further stock available which posed a risk to the continuity of all global sites involved in the clinical trial. The Client discussed their requirements with RenaClinical who managed to source 30,000 packs of the equivalent EU-based comparator stock within 2 months of the initial request. This ensured the continuation of the clinical trial.
RenaClinical also enabled the Sponsor to extend the shelf life of the IMPs. This was achieved by performing a stability study on the active IMP at both accelerated and long term conditions. Data from the accelerated stability study was used as justification for an expiry extension that enabled supply to continue whilst new comparator stock was sourced. RenaClinical also provided the Client with expiry extension over-labelling of stock within the RenaClinical warehouse and re-certification. For existing IMP stock within local trial sites RenaClinical provided new expiry date labels and labelling instructions for all sites to ensure all labelling activities with performed appropriately and in regulatory compliance.
RenaClinical was pivotal in providing solutions to reduce the global shipment costs of the IMPs. RenaClinical performed transportation stability studies on the active and placebo IMPs to demonstrate that wide fluctuations of extreme temperatures had no negative effect on the quality and safety of the IMPs. As a result of the study the IMPs can be shipped with no temperature control which provided a huge transport cost saving to the Sponsor whilst maintaining regulatory compliance.
Import, labelling & EU Distribution
A Swiss-based client contacted RenaClinical to request IMP importation, labelling and QP release services for their leading pipeline product. The IMP was manufactured in China and required importation into the EU for clinical trials being run in Italy. RenaClinical utilised approved 3rd party GMP auditors of the Chinese facility to enable QP GMP declaration to be submitted with the CTA application. The audit was arranged and executed within 2 weeks to enable the QP GMP declaration to be submitted in line with the Client’s deadline for CTA submission. RenaClinical performed all IMP importation, labelling and QP release on behalf of the Client. The Client has continued to utilise RenaClinical’s services for other projects and have been particularly impressed with RenaClinical’s Brexit mitigation plans.
RenaClinical was contacted via a Singaporean Biotech company that had run into issues relating to the importation of their biosimilar IMP into the EU. After numerous problem solving meetings and discussions RenaClinical provided a bespoke solution to the client’s needs. RenaClinical managed to perform IMP importation & QP certification within 4 weeks of contract sign-off. This was achieved via RenaClinical’s hard work and dedication to achieving the Client’s goals. RenaClinical has continued to work closely with this Client and is now their primary partner for importation & certification services for their EU clinical trials.
Cellular Therapy - Decentralised manufacturing
RenaClinical was approached by a London-based research organisation to review the feasibility of their ultra-orphan product being suitable for use as an IMP in a EU clinical trial. The Client was turned away by a number of other Clinical Trial Service providers and RenaClinical was their final port of call. The main issue surrounded the shelf life of the IMP. Once manufactured the IMP had a 30 minute shelf life prior to subject administration. Given this shelf life limitation a decentralised manufacturing (DCM) process was recommended by RenaClinical as the only viable option for IMP manufacture. The proposed DCM process is based on the EU ATMP GMP guidelines which permits local trial site manufacturing and retrospective QP certification for time critical IMPs.
RenaClinical worked closely with the Client to develop this bespoke process. RenaClinical QPs successfully presented this proposed process to the MHRA & EMA during scientific advice meetings and a UK CTA was approved in December 2018. This process enabled the clinical trial to be authorised as is the first step in the commercialization of this novel product.
Cold Chain Packaging
A US-based biotech company was referred to RenaClinical via one of RenaClinical’s existing clients. The US Client chose RenaClinical to import their Orphan designated IMP into the EU. The IMP was a cold chain product requiring storage at 2-8C. In order to meet the Client’s schedule, RenaClinical installed and validated additional cold storage capacity within its UK facility within 2 weeks of contract approval. 3,000 IMP vials was imported one week later and subsequent labelling & packaging was performed within the following 4 weeks. The packaging requirements for this IMP was complex as each vial required packaging into foil pouches with addition of desiccant & oxygen scavenger. RenaClinical utilised a manual packaging process in order fulfill this complex packaging requirement.