The puzzle that is pharmaceutical drug development can be both complex and multifaceted. A journey that requires the seamless integration of various disciplines, it is our ultimate goal as Contract Research Organisations or ‘CROs’ to help demonstrate the safety, efficacy, and regulatory compliance of new therapeutic agents for the betterment of human health and wellness.

Two pivotal pieces of this puzzle are the  Regulatory Affairs and Clinical Research disciplines. Done well, they offer numerous benefits that can accelerate and streamline the drug development process and support you to get to market quicker. Going in the opposite direction they can be a key contributing factor in blowing out budgets and timelines, and ultimately not delivering for end users who stand to benefit from life-changing treatments.

While creating synergy across these sometimes disparate parts of the drug development process is often easier said than done, there are certainly cost-effective and clear pathways available. Here are several insights into how we, at Accelagen, take a collaborative and patient-centred approach to the drug development process that results in tangibly better outcomes for both patient and sponsor.

Streamlined Regulatory Compliance

The regulatory landscape for pharmaceuticals is intricate and constantly evolving, with stringent requirements set by regulatory authorities worldwide. With a team of experienced regulatory affairs professionals, led by Greg Plunkett, we have become adept at navigating these complexities and manoeuvring them to our advantage. Our goal is ensuring that the drug development pathway achieves the desired outcomes, at the same time as adhering to relevant guidelines, laws, and standards.

One way we do this is by incorporating clinical input at key stages of the regulatory process. Keeping your strategic objectives in mind, our team draws on existing knowledge to help forge a regulatory pathway, identifying any potential gaps in the regulatory information along the way.

Working closely across our co-located clinical research team, we are able to proactively address potential regulatory challenges, and optimise trial design for a smoother pathway to approval:

“It is our unique approach to process that focuses on asking the right questions, getting the right team in place early on, and ensuring clarity on the outcome to devise the right pathway that creates the impressive differential in the outcomes we generate for our clients.” — Accelagen CEO, Greg Plunkett [Negative to Positive Case Study]

Enhanced Trial Design and Execution

Accelagen’s unique combination of clinical research knowledge and regulatory expertise fosters the creation of well-designed trials that align with regulatory requirements from the outset. Why is this important? Regulatory insights ensure that trial endpoints are aligned with both clinical and regulatory objectives, avoiding costly modifications later in the process and maximising the likelihood of a consistent outcome.

In addition to this alignment, combining regulatory and clinical perspectives enhances patient safety by developing rigorous protocols and monitoring procedures, which can lead to more reliable and ethical clinical trial outcomes. We are also of the belief that clinical research is about far more than just testing a new therapy in a group of trial participants. It is about creating measurable improvements for people’s health and wellbeing that will impact generations to come.

Accelerated Development Timelines

One of the most significant advantages of bringing regulatory and clinical experience under the one roof at Accelagen is the potential to expedite drug development timelines. With over 50 successful marketing applications completed, more than a dozen IND/IDE submissions and 350+ Device Approvals, we are proud of our record fast-tracking market authorisation and heading off roadblocks before they occur.

Delays in regulatory approvals and clinical trial execution can significantly impede a drug’s path to market. By deliberately combining these two disciplines, Accelagen’s vastly experienced teams can proactively identify potential roadblocks and implement strategies to mitigate them. This approach helps to streamline regulatory submissions, address compliance issues promptly, and anticipate challenges in clinical trials. And ultimately, it reduces development timelines and helps our clients bring much-needed treatments to the patients that need them, faster and safer.

Optimised Risk Management

Risk assessment and management are integral components of both the regulatory and clinical sides of this work. When integrated, teams can comprehensively evaluate risks from multiple angles, ensuring a more holistic risk mitigation strategy. This helps to combat potential compliance risks and identify safety concerns before they occur, with the Accelagen team able to create more robust risk identification and management plans.

At Accelagen, we are proud to offer best-in-class and in-house regulatory affairs, to ensure we can minimise friction and create seamless pathways to market authorisation. This then also minimises the likelihood of unexpected setbacks and fosters a more proactive response to emerging issues during the development process.

Improved Communication and Collaboration

Employing a unique approach to process and people, Accelagen not only works side by side with our clients to co-create meaningful outcomes that have a tangible impact on the future of human health, but we walk the walk internally. Our proprietary process integrates a collaborative, patient-centred approach across all of our in-house teams, and this drives the industry-leading outcomes we generate for our clients.

At its core, our approach is centred on collaboration and communication. Sharing knowledge and expertise generously, and breaking down any silos that may exist to form a holistic picture of the drug development pathway. 

Our work is first and foremost about accelerating and improving the future of human health. By embracing a deliberate and dynamic integration of clinical research and regulatory affairs, the outcomes we offer to our clients are greater than the sum of their parts.

As we strive to develop safe and effective treatments for conditions across the disease spectrum, this approach is the key to unlocking the full potential of efficient and effective drug development, while navigating a complex and ever-changing regulatory environment.