The case for consistency
Why retaining one CRO partner during all phases of clinical development drives better outcomes
The journey from non-clinical and early phase research to market entry is complex and filled with challenges. To navigate this environment, companies must focus on maintaining a clear strategy that mitigates, to the extent possible, the risks and challenges.
Retaining a single CRO partner throughout the entire lifecycle of a compound or device development provides the consistency needed to overcome these obstacles and achieve development goals.
Continuity drives success
Switching Clinical Research Organisations (CROs) during the development process may seem like a viable option for reasons such as cost saving or specialized services. However, this decision often introduces more hurdles than it pertains to resolve.
Retaining a single CRO partner throughout the product development cycle and through the different types and phases of clinical studies allows the involved team to build a deep understanding of the product and its unique characteristics, enabling anticipation of potential obstacles and allowing knowledge obtained from previous solutions to be applied for mitigating new challenges.
Moreover, the CRO partner team will become a true extension of the sponsors team, allowing seamless collaboration including full understanding of preferred ways of working together.
In addition, operational inefficiencies of switching CROs can be significant and can have the undesirable impact of decreased quality, extended timelines and escalated costs. Transferring knowledge to another partner, with the risk of it being incomplete, negotiating contractual terms between the Sponsor and the new CRO, retraining new teams, and aligning them with the established processes, all require substantial time and effort, often leading to delays, miscommunication, and increased costs.
Additionally, inconsistencies in trial designs, data collection, and reporting resulting from a change in CROs may compromise regulatory compliance and delay critical approvals.
Thus, in a competitive industry where every day counts in getting new products to market, it is advantageous to reduce these risks by finding a full service CRO that has the capabilities, a partnership collaboration model and can deploy its services during the entire development cycle.
How Astrum’s integrated offer benefits sponsors
Aiming to meet this need for an end-to-end solution, Astrum offers a full range of clinical development services spanning the entire drug development life cycle. From scientific and operational expertise in early-stage study design and conduct, to the close relationship with high performing clinical sites ensuring participant recruitment and data integrity, we support our sponsors with the full-service from Phase I to Phase IV, as well as non-interventional studies and non-clinical development advice.
The safety of all study participants is our highest priority. Our medical, scientific and pharmacovigilance experts provide advice and guidance to sponsors and sites, whilst monitoring the safety of the IP/device throughout the duration of studies and ensuring compliance with reporting requirements.
All of these studies are supported throughout by our experienced Data Services team who design eCRFs that simplify data collection in accordance with the study protocol, clean the clinical data to ensure it is complete and accurate, perform statistical programming and analysis, and ultimately write high quality clinical study reports. This ensures our sponsor’s studies are scientifically valid and produces reliable results that will be accepted by regulatory authorities.
Case study: ensuring success through continuity
A Portuguese pharmaceutical company set out to develop an innovative treatment for rheumatoid arthritis. With a promising new molecule, they required a CRO partner capable of guiding them from the earliest research stages through to clinical validation. Astrum provided critical support throughout the process, ensuring a streamlined and efficient pathway for the clinical development of the sponsor’s exciting product.
From the outset, Astrum assisted with non-clinical advice, helping to optimize study design and ensuring that the preclinical data would support the robust clinical development plan. As the project moved into human trials, Astrum designed and conducted the First-in-Human study, ensuring regulatory compliance and safety of participants while collecting valuable early data.
With promising initial results, Astrum continued to support the sponsor by conducting a Proof-of-Concept clinical study, enabling the team to demonstrate the therapy’s potential efficacy in patients.
Through continuous collaboration with Astrum, the sponsor minimized delays, optimized regulatory interactions, and ensured consistent data integrity from non-clinical studies through to early-phase clinical development.
Following the First-in-Human study, the sponsor decided to change the route of administration for the product. Astrum, already leading the phase I study, efficiently supported the design of the necessary non-clinical bridging studies for the new formulation. The continuity and scope of Astrum’s capabilities significantly reduced the time for the non-clinical study design phase to 1 month, a process that can take 5/6 months. If the Sponsor had selected to engage with a new CRO partner there would likely have been long concept discussions and potential risk of knowledge gaps and delays.
Additionally, Astrum’s involvement from the start, allowed the Astrum medical, scientific and operational teams to engage early with key opinion leaders (KOLs) during the initial development stages. This proactive engagement facilitated the identification and fostered motivation of the Principal Investigators in later phases, including the Proof-of-Concept clinical study.
This close collaboration between the KOLs and the Astrum team played a crucial role in accelerating development timelines by improving patient identification by motivated physicians, and enhancing the overall success of the clinical program.
This case highlights how a single CRO partner with expertise across all phases can streamline drug development, through transferring knowledge, creating efficiencies by using the same tools & systems, mitigating risks and accelerating progress towards market approval.
The right partner for the full journey
The complexities of clinical development demand more than just technical expertise – they require a partner who understands the overall clinical development objectives of the sponsor and the actual journey from start to finish.
Retaining a single, capable CRO like Astrum throughout the entire development cycle ensures that knowledge is preserved, processes remain streamlined, data capture and reporting is consistent, complete and to the highest quality, regulatory pathways stay clear, providing significant efficiencies and overall reduced cost and accelerated development timelines.
At Astrum, we are committed to being that partner. By providing full service support from non-clinical development through market entry, we enable our Sponsors to navigate the road to approval with confidence. We will be your partner ensuring that every clinical program benefits from consistency, efficiency, and expertise at every stage.