Imagine a world where we can arm the body's defenses, pre-emptively training the immune system to unleash a formidable army of tumor-fighting cells. While preventive vaccines have triumphed against specific cancer types, the journey to unlock the true potential of therapeutic vaccines has been a formidable challenge, marked by trial disappointments that initially dimmed the spark of enthusiasm ..read more

The clinical research industry has been affected by a widespread talent shortage, an uncertain financial environment and a weakened economy. These challenges extend beyond the immediacy of hiring needs, urging many organizations to adopt a unique strategy—an approach that goes beyond the standard, a call for aligning long-term talent strategies with organizational objectives and a Total Talent Ecosystem (TTE ..read more

In the ever-evolving landscape of biopharmaceutical development, the challenges of working in an internationally growing company are both exciting and complex. As companies expand globally, maintaining effective communication and upholding stringent quality and compliance standards become paramount. For small- and mid-size pharma companies, as well as emerging biotech companies, the journey of growing and expanding into new geographic regions necessitates a holistic approach to quality and compliance. It's about building a system that stands the test of time — a system founded on bedrock prin ..read more

The Asia-Pacific region is rich in opportunities for the biopharmaceutical sector, home to over 60% of the global population and with a diverse range of diseases and patient profiles. With rapid expansion economically, the region offers efficient clinical trial infrastructures, well-grounded manufacturing capabilities, and government policies favoring growth. According to GlobalData, over half of future global clinical trials will encompass the Asia Pacific region, making it pivotal for biopharma research and development ..read more

In every clinical trial, the role of patients and their caregivers is pivotal. Caregivers not only offer essential emotional support but can also play a significant role in helping patients navigate the complexities of their medical journey. As Sponsors and contract research organizations (CROs) seek to improve patient experiences and broaden their outreach, it's crucial to recognize the unique and important role caregivers play in clinical trials ..read more

The landscape of the biopharmaceutical industry is ever-evolving, and the challenges it faces in staffing critical roles persist. With recent reports underscoring the preference of self-employed individuals for salaried positions, the demand for a more effective approach to recruitment and talent retention has never been more pronounced. In a field where clinical trials and research projects hinge on the expertise of skilled professionals, the biopharma industry grapples with the need for cohesive teams and rapid program execution under increasingly tight timelines. As lean R&D budgets an ..read more

Clinical development is a high-stakes endeavor. Companies invest vast resources, both in terms of time and money, to bring new therapies to market. However, given the macroeconomic environment and industry-wide uncertainties, the margin for error has never been slimmer. Sponsors must hit the bullseye with their clinical trials on the first shot. In this context, the importance of forging authentic partnerships with clinical development providers cannot be overstated. It's not merely about engaging a Clinical Research Organization (CRO), Functional Service Provider (FSP) or strategic resourcin ..read more

As the world’s third largest pharmaceutical market, Japan is critical for pharmaceutical companies looking to develop and commercialize new medicines. Its advanced healthcare system, strong R&D infrastructure, and supportive regulatory environment present enormous opportunities for drug developers to expand market access while positively impacting public health. Yet entering the Japanese market also presents several cultural challenges and navigating a regulatory process that — if not mitigated prospectively by selecting the right partner — may hinder clinical and commercial success ..read more

Serious staffing shortages affect nearly all aspects of healthcare, clinical research included ..read more

The decision to change contract research organizations (CROs) for an ongoing study is not an easy one, but sometimes a move is necessary. The CRO may be underperforming, lack adequate resourcing, undergoing a merger or acquisition which can compete for priorities, or some other type of scenario that questions their ability to deliver and execute the study effectively and efficiently. Once the decision is made to transition, care needs to be taken to ensure a thorough plan is in place and details addressed to ensure all stakeholders are set up for success. While momentum builds to get activiti ..read more