Global regulatory standards for clinical trials are, simply put, complex. In this case study, learn how one company worked with its partner to overcome the challenge of a protocol based in the US, an investigational medical product (IMP) approved in the EU, and varying QP (qualified person) rules from country to country, to conduct their clinical trial in Isreal.
With our team of packaging experts and extensive cold chain capabilities, this case study discusses the creation a custom packaging and distribution solution to meet this client’s unique needs. Through our partnership, the product was successfully packaged in sufficient quantity and on time for the Phase I trial.
Polysorbate-80 (PS-80) is a surfactant commonly used as an excipient to improve API stability. However, degradation of PS-80 can lead to decreased drug potency or stability, and there is inconsistency in the quality and composition of PS-80 provided by different vendors.
Current state-of-the-art continuous manufacturing technologies are being developed and implemented to manufacture a wide variety of products including monoclonal antibodies, recombinant proteins, and other biological modalities. Though upstream fed batch and perfusion bioreactors unit processes are relatively mature, downstream process unit operations are less mature. In this case study, Catalent compared the productivity of purifications running in batch versus continuous mode.
Clinical labelling is a function that has the potential to make or break a study, depending upon design and execution. A function that was once seemingly on the periphery of clinical trial management has now taken on a new level of significance with increasingly complex labelling requirements. This case study highlights the complexities involved in label design and execution and how Almac worked with one sponsor to identify and rectify a flawed design to ensure a seamless trial, an improved patient experience and enhanced overall trial performance.
Investigator Initiated Trials (IITs) play an important role in helping sponsor companies better understand their drugs. However, managing these studies presents unique and complex clinical supply chain challenges. Download the case study to find out how Almac Clinical Services helped one biotechnology company effectively manage drug supply for multiple IIT programs.
Pharmaceutical manufacturers use a range of marketing channels to promote their prescription drug product. In the United States, one of those channels is to have Pharmaceutical Sales Representatives ‘hand carry’ samples to the health care practitioners within their territories.
To deliver consistent results and ultimately create lasting relationships with sponsors, ARA needed fast and flexible eClinical tools. Medrio offered the ability to set up studies easily, collect data accurately, and make mid-study changes without study downtime saves their clients time and money - and increases the likelihood of repeat business and referrals.
Learn how a Phase I unit in Australia leverages Medrio DDC to reduce paper usage by 95% and monitoring visits by 50%. This case study provides holistic insight into DDC vendor selection, implementation, and results.
Site selection and ensuring that sites are performing up to par are crucial parts of a study. Read how a CRO facilitated communication between participants and sites and personally took measures to follow up with participants who would have been otherwise lost between screening visits.
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