Many of the trends driving this industry are based within the regulatory guidelines, but there is also a growing reliance on technological advancement.
This is evidenced in the managing of non-CRF data which is now electronically captured in cloud systems with full or functional outsourced services. We understand that CDM must now strategically cover the entire project development data lifecycle. This is performed by professionals with not just the analytical and management ability to lead the internal process, but increasingly the external resources contracted out.
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The rise in costs of clinical research has been driven by innovation within the technology field, the rapid rise of data science and larger trial sizes.
The necessity for companies to augment value and control expenditure has become of paramount importance. Streamlining R&D is necessitating higher demand for professionals who understand how to make the most out of RWE (Real world evidence), shorter clinical trials, outsourcing and smart research.
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Drug manufacturers are investing heavily in Pharmacovigilance as public awareness of drug safety heightens.
At the same time companies are relying on signal detection technologies to detect and manage unfavourable drug events as early in the lifecycle as possible to reduce the occurrence of drugs being recalled from the market. At the same time, Pharmacovigilance Outsourcing is receiving greater prominence. Each year the management and reporting of adverse events becomes more complex. One example being the changes to the Eudravigilance system for reporting adverse events in Europe. We work with clients to keep up to date with the support required from specialised experts.
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Health Economics & Outcomes Research has developed at a rapid pace, driven by both governments and other interested parties determined to push value in their healthcare decision making process.
We work closely with clients to identify experts who can add value and insight into this rapidly changing area of balancing of incentives for research with pricing of breakthrough therapies. With drug pricing, innovative and curative therapies, accelerated/expedited drug approvals and the evidentiary needs required for reimbursement being key issues, this is an area where insight in identifying the key talent is imperative.
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Pharmaceutical manufacturing continues to evolve with increased emphasis on science and engineering principles.
Over recent years the rise of Continuous Pharmaceutical Manufacturing has overtaken in popularity that of batch processing, both in process development and manufacturing for the pharmaceutical sector. There is also a drive for greater scientific and ... ... regulatory readiness for continuous manufacturing with the widespread adoption of the QbD paradigm and PAT. The barriers to market entry are reducing and therefore many of our clients are looking for professionals who can lessen costs and optimise their operations throughout the pharmaceutical manufacturing process.
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Medical Affairs in the pharmaceutical industry continues to evolve from a support to an invaluable strategic function.
Medical Affairs professionals are on the front-line with all stakeholders and contacts. Medical Affairs departments are increasingly being challenged to demonstrate their financial value. Therefore we work with our clients to identify talent that has the technical and commercial ability.
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The pharmaceutical industry is a unique and highly regulated industry. With three distinct voices: patients/consumers, healthcare practitioners and the pharmaceutical industry, it is important that all three are listened to and represented.
The key areas of focus within medcomms are anchored in co-design/co-creation and strengthening engagement using ‘personas’ and data to develop a more personalised experience. We ensure that those we represent are not only capable of, but understand why it is important to, deliver content that is unambiguous.
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There are no shortages in the challenges being faced within quality assurance.
Product development and change is regularly the biggest. Ongoing changes to regulatory guidelines and manufacturing technologies are also introducing challenges that many QA professionals are having to face up to. Data integrity and Quality Oversight Metrics are areas where technology is beginning to play its part. Alongside these, the concept of Pharma 4.0 continues to gain traction Therefore, identifying professionals with more than regulatory knowledge, but those who can process analytical technology, is where much of the focus of those companies hiring is centred.
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Regulatory affairs professionals undertake varied yet distinct roles within the drug, med, or device lifecycle.
From initial concept throughout the developmental phase and through to approval and launch, each element requires professionals with specific expertise, in a range of niches from clinical data collection to capturing and reporting adverse events. We work with clients to identify well-rounded professionals who understand the overall regulatory landscape and can help companies effectively bring products to market.
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There has been a significant amount of money invested in the pharmaceutical and life science industries.
At the same time, the amount of regulation over these industries is also multiplying. This has lead to an explosion on the amount of R&D being undertaken. Developing effective, safe and affordable drugs now requires a targeted and data-driven approach. We are supporting our clients who are looking towards their R&D solutions and integrating data, utilising greater analytics and leveraging new technology to facilitate the data-driven drug discovery and development decisions.
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Scientific and engineering professionals are increasingly becoming important to the discovery, development and manufacturing of new products.
There has been a significant growth in both pre-clinical research, addressing experimental protocols and establishing sequencing instruments. One of the biggest areas to have been impacted in recent years is the way pharmaceutical companies now outsource their scientific and engineering to research and manufacturing companies. The rise of the 'virtual pharmaceutical companies', is fuelling demand in this sector. There is also a strong movement towards scientific and engineering roles being centred in academia-industry hybrid companies.
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Whilst regulatory driven change is significant, the key driver in this area continues to be technology.
With the maturing of DMS (document management systems), there is a direction of travel towards the statistical programming arena. Where there is less agreement is where in the statistical programming process these technologies are integrated. However XML has emerged as the standard for data interchange. We are therefore working with many organisations looking to build internal expertise in XML. programming. Similarly, data warehousing tools to automate and control processes of creation of datasets is also gaining in popularity. Centralised statistical monitoring is also becoming increasingly relied upon by organisations looking to develop risk-based monitoring with real-time, accurate metrics. Consequently, data analytics will play an even greater role in crucial strategic decisions.
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Manufactures within the medical equipment and device industry are beginning to realise the benefits of big data and analytics, artificial intelligence, and new digital tools, which continues to present unparalleled opportunities for growth.
All manufacturers are continuing to define and execute regulatory strategies but are also focused on technological developments regarding 3D printing, cyber security and digitalised devices. In addition the volume-to-value transformation is increasingly a focus for medical equipment firms.
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