A day in the life of a programmer at PHASTAR Nairobi

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.

Continue Reading

Digital trends in clinical data management

Digital trends in clinical data management

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.

Continue Reading

Challenges and opportunities of rapid clinical trials for COVID-19

Challenges and opportunities of rapid clinical trials for COVID-19

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.

Continue Reading

A day in the life of a programmer at PHASTAR Glasgow

I started my career as a programmer in June 2016, when I joined the PHASTAR graduate programme and started work in the Glasgow office. I had just completed my BSc in Mathematics at Glasgow University. Since then, I’ve gained experience on a variety of studies and am now a senior programmer and line manager. At PHASTAR, a day in the life of a programmer is always interesting and varied!  Here is an example of a typical day (during lockdown!).

8.30am:

I get settled at my desk (which is currently in my spare room due to COVID-19 lockdown!) and check my emails. I plan my workload and prioritise the tasks to complete by the end of the day, taking into account any meetings that I have scheduled.

9am: 

I’m currently working on the CRT package for my project, alongside some ad-hoc TFL updates, so I start my day by completing some updates that were required to the SDTM annotated CRF, which we have been working on for the duration of the programming for this phase I-II project.

Continue Reading

View from the summit: The Best Laid Plans...Navigating Uncertainty During COVID-19

Day 2 of PHASTAR’s Life Science Summit began with an insightful and engaging plenary panel discussion with Dr. Janet Wittes, Prof. Stephen Senn and Prof. Frank Harrell, focusing on “The Best Laid Plans...Navigating Uncertainty During COVID-19”. Each panelist gave a short presentation, followed by a lively Q&A session chaired by PHASTAR’s Head of Statistical Research, Prof. Jennifer Rogers.

Dr. Wittes kicked off day 2 delivering a candid assessment of how the COVID-19 pandemic has changed her thinking on a variety of aspects of clinical trials while pondering on if, and how, future clinical trials will ever look post-COVID-19. She highlighted the fact that presently there are over 500 COVID-19-related clinical trials and the number is growing. A key aspect of her talk focused on how we might use this unfortunate situation to learn and adapt our approaches so in the post-COVID-19 settingclinical trials might be more efficient and better designed.

Continue Reading