Functional Service Provision (FSP) and Full- Service outsourcing models have been hotly debated topics over the past decade. Of course, both have their places in the market however market share shifts between the two have certainly been observed. As service providers continue to match their offerings with customers' wishes, hybrid models of FSP and Full-Service have emerged on the market.
The pros and cons of each model are well worn. Those who advocate the Full-Service approach often note the ‘one-stop-shop’ benefit - the simplified contractual arrangement, the integrated team, alongside the potential for cost savings both in efficiency and increased bargaining power, particularly if a sponsor awards several programs of studies to a single provider. Supporters of FSP often point to access to specialist providers, similar cost savings from efficiencies, flexibility on team size and the ‘plug-and-play’ nature of functional contracts.
Working in programming is an interesting, exciting career and so are programmers just like me. No day as a programmer is the same, since we jump from standardising non-CDISC (Clinical Data Interchange Standards Consortium) data to CDISC by programming datasets through applying consistent data structure/format and data mapping. We also generate tables, figures and listings. We achieve this by utilizing SAS programs and macros. Besides, we handle myriads of studies which not only keep us engaged but also increase our experience and knowledge.
At PHASTAR, we create solutions to different problems especially in the field of medicine. It’s very fulfilling to know that you are part of the greater good, helping to find solutions through medicine development, ultimately making lives better. Consequently, our work calls for keenness, independence and self-discipline.
Below is a glimpse of my typical working day at PHASTAR.
Digital technology has transformed most, if not all aspects of modern life and industries. The pharmaceutical industry has certainly not been left behind in the drive for innovative use of technology to improve how clinical trials are conducted.
Successful trials require accurate data for endorsement of the study and final product – be that medication, device or therapy. Paper based data collection can leave room for errors during migration to electronic format which can compromise quality. This necessitates the need for digitalisation of data capture using eCRFs which has a multitude of benefits including a reduction of operational costs, further enables timely access to records within a secure storage and increases trial efficiency. PHASTAR has established successful partnerships with two leaders in electronic data capture, Medidata and Medrio, which allows us the ability to provide cost-effective EDC solutions to clients, in all aspects of clinical trial research from Phase I-IV as well as being accredited to build and administer EDC, eCOA, Coder and RTSM in-house.
As of 18th August 2020, there have been 21.6m confirmed cases of COVID-19 and 770 thousand deaths worldwide. Conducting trials of novel interventions during infectious disease emergencies is crucial for determining the efficacy of potential vaccines and therapies. When thinking about the timeframe from initial drug discovery to regulatory review, we need to embrace novel clinical trial designs that improve efficiency so that these new therapies can be identified quickly. The term “master protocol” refers to a general framework whereby multiple parallel drug studies are operated under one overarching protocol. Master protocols are classified as basket, umbrella, and platform trials. They are novel designs that investigate multiple hypotheses through concurrent sub-studies, offering enhanced efficiency and a more ethical approach to trial evaluation.