Blog
Ada Lovelace Day 2023: turning curiosity into a career
In this interview, Dr Karen Mullen discusses what inspired her to pursue a career in STEM, her tips for overcoming adversity, and how to encourage more women to consider careers in the industry.
Clinical study management: the key to trial success
In our latest blog, Dr Karen O’Hanlon sets out the approach the team follows to help maximise trial success.
Considerations for US Biotechs looking to set up gene therapy studies in the UK and Europe
In our latest blog, Clinical Project Manager, Chris Moore explores the key challenges faced by US biotech companies planning to initiate their gene therapy study in the UK or Europe.
European Commission proposes extension of Medical Devices Regulation transition period in bid to prevent medical device shortages
At the Employment, Social Policy, Health and Consumer Affairs (EPSCO) meeting on 09 December 2022, the European Commissioner for Health and Safety, Stella Kyriakides, put forward proposals in her opening speech to extend the transition rules of the Medical Devices Regulation (EU) 2017/745. The Medical Devices Regulation (MDR) was adopted by the European Parliament and the Council in 2017. The Regulation states that medical devices can be placed on the EU market under CE certifications issued in accordance with Directive
What is a Target Product Profile and when is it needed?
When embarking on a journey it is preferable to have a destination or end goal in mind. The same is true when developing biopharmaceutical products; having an end goal or milestone to target helps keep the project team focused on what is required to reach the desired endpoint. A Target Product Profile (TPP), as the name suggests, defines the desired characteristics of the product, and is generally developed by the R&D project team, and in larger biotech and pharmaceutical companies,
Mitigating the risks with scientific due diligence
The need for scientific due diligence When companies enter into a deal, the successful outcome of that deal is subject to both parties working together to share information until an agreement can be reached. For biotech and life sciences companies, this is often achieved through scientific due diligence. Due diligence carries the simple understanding; you get what you expect and there are no surprises. What are clients looking for from the due diligence process? As an initial step in the
Navigating the challenges faced by Medical Directors
The role of a Medical Director is not only the key to the success of the medical department but secures medical as a key strategic Partner. This however is not always straightforward to achieve with competing priorities and views. Our experienced team has first-hand experience with the challenges faced by Medical Directors every day. Dr Karen Mullen, Chief Medical Officer at Boyds explains how getting the right support can help Medical Directors to excel in their role, navigate the challenges,
Medical monitors in clinical trials: the linchpin between patients and sponsors
Medical monitoring is an essential component of clinical trials: ensuring participant safety and data integrity. This medical oversight is often thought of as part of the sponsor team, our independent medical monitors (MM) at Boyds work on behalf of the sponsor, providing oversight across multiple study sites or multiple separate clinical trials. Boyds has a long history of providing independent medical monitors, founded on a broad scope of expertise, frequently in collaboration with internal clinical operations and strategic activities. Maximum
