Even prior to the pandemic, medical and pharmaceutical companies faced increasing pressure from competition. These pressures resulted in the need to reduce cost, constrictive regulatory hurdles, and regional instability ranging from Brexit to, more recently, the current conflict in Ukraine. The pandemic has only accelerated these challenges, even while adding significant expenses and delays due to the uncertainty surrounding traditional clinical trial methods given current global challenges.
In-house drug development tends to take an especially long time, and the pandemic has further increased the likelihood of delays and bottlenecks in the research process. Despite a market decline of 6% in 2020 as a result of the Covid-19 pandemic, the market size of global clinical trials is expected to grow to USD 78.3 billion by 2030 and companies must acclimate to this new environment.
To stay flexible and respond to a rapidly changing market, one must adapt to exponential knowledge growth globally, advancements in evolving technologies, and an increasingly unstable global economy. As we will see below, outsourcing clinical trials to a contract research organization (CRO) eases this transition significantly, putting pharmaceutical companies on much stronger footing in a post-pandemic world.
Benefits of outsourcing to CROs
Reduced expenditures – Given the current climate surrounding clinical trials, outsourcing is in large part a risk mitigation strategy, as many drug manufacturers have seen a drastic reduction in profits as a result of the pandemic and its knock-on effects. Outsourcing means that pharmaceutical companies no longer need to hire, train, or oversee clinical research staff as part of their in-house R&D teams or other infrastructure.
Traditional clinical trial models rely on large, often local, patient groups coming to hospitals or clinical sites. This type of process is difficult to manage and cumbersome to oversee, while only including relatively narrow demographics. Although patient recruitment and retention has historically been a challenge in the industry, the pandemic has moved more processes online, forcing companies to adapt their operations as the shift towards “virtual” accelerates.
The use of social media for patient recruitment gives CROs a far better rate of success in outreach and engagement, which can lead to higher profits for their pharmaceutical clients.
Complex clinical trials – Better community engagement and a “patient-centric” approach are the way forward. Drug development has become more complex in recent years – due in part to gene therapies and antibody drug conjugates – requiring more sophisticated clinical trials.
By focusing exclusively on trials, CROs can provide tailored solutions with higher standards of accuracy and efficiency than in-house clinical trial models.
Decreased time to market – The ability to rapidly scale up and scale down is another benefit to partnering with CROs, as it streamlines bottlenecks and greatly decreases time to market. A good CRO partner will have the skills and organizational competence to provide services at a higher level of efficiency, no matter the size of the project.
From patient recruitment, to data collection, to the final drug approval, a shortened lead time allows pharmaceutical businesses to see a market return on their products much sooner.
Challenges of outsourcing clinical trials
Lack of transparency – Communication is paramount in a successful sponsor-CRO relationship. This means that proper implementation depends on the issuance of clear directives, objectives, and expectations.
Moreover, the pandemic has moved the industry and regulatory bodies towards fast-tracking clinical trials given the urgency for new drugs and treatments, and so having proper protocols, methodologies and best practices in place is absolutely necessary. The establishment of deliverable acceptance criteria must be developed from the outset.
Both during and after the trial, the need for clear lines of communication is also important. If CROs do not update their sponsors regularly with new information, the sponsor’s confidence in the CRO will decline. Conversely, CROs must remain updated on any changes to regulatory requirements or safety issues, as well as any adjustments to trial objectives or desired scope.
Long timeline – Sometimes clinical trials can experience delays, which increase overall costs and create scheduling issues. A competent CRO, given its complete focus and specialization toward the task at hand, can adapt to rising complexities at any stage of development. Their ability to make real-time adjustments can shorten lead times, for the benefit of their clients.
An example of such adaptation involves automated data collection, enabling the aggregation of data from multiple sources. Streamlined reporting tools can also reduce the burden of this data collection, improving communication to facilitate a smoother ecosystem between the sponsor and the CRO.
Sponsor-CRO partnerships are the future
Pharmaceutical companies should choose a CRO partner whose facilities can accommodate their type of product, and whose infrastructure is equipped to finish the project within the desired timeline.
By selecting a CRO with a proven track record, clear organizational model, and measurable performance indicators, drug companies can develop strong relationships that become even more efficient over time. As a partner, Clinixir can provide high-quality clinical trial services that will meet and exceed client expectations. Contact us today to learn more.