Phastar is now a B Corp™ - what, how, and why?

Written by PHASTAR on 11 July 2023. Posted in Blog

We are absolutely delighted that Phastar is now a certified B Corporation®, effective from June 2023. We are proud to be a part of this community (covering 6,800 global companies) and to reaffirm our objective to lead the CRO industry in corporate social responsibility!

What does it actually mean to be a B Corp™?

B Corps™ are organisations that uphold the highest social and environmental standards, underpinned by a dedication to remain sustainable, transparent, and accountable. B Corps™ are both profit and purpose driven and consider the impact of the decisions across a multitude of areas both internally and externally.

Attaining this certification asserts our commitment to leading in the global movement for an inclusive, equitable and regenerative economy. It is our declaration to use our business as ‘a force for good’ by creating tangible value for our workforce, the communities we serve and society as a whole.

Why did we want to be a B Corp™?

As a purpose-driven organisation, our commitment to patient well-being and employee satisfaction naturally aligns with the principles of sustainability and social responsibility. We understand that our success goes beyond financial metrics and encompasses our impact on the environment, the communities we operate in, and the stakeholders we serve. Therefore, becoming a certified B Corporation was a logical step for us to hold ourselves accountable and transparently demonstrate our dedication to these principles.

Decoding the HTA Craze: A closer look at the exciting world of health technology assessment (HTA) at PSI 2023

Written by PHASTAR on 10 July 2023. Posted in Blog

There is always an excited buzz around one or two hot topics at statistics conferences, and PSI 2023 was no exception. Previously, it’s been estimands, or real world evidence. This year we were all talking about HTA. But what is it? And why the buzz now?

According to the European Commission (EC), a health technology assessment (HTA) is a “procedure for assessing the added value, effectiveness, costs and broader impact of health care interventions including medicines, medical devices, surgical procedures”.¹ The EC describe two HTA domains – clinical (relative clinical effectiveness, relative safety, description of health technology under assessment) and non-clinical (economic evaluation, ethical aspects, organizational aspects, social aspects, legal aspects)¹. Methods and assessment criteria can vary across countries to suit the clinical and legal requirements leading to a large number of HTAs for a single medicine. There are important differences between regulatory assessment and HTA but perhaps a suitable analogy is that imagine you have created a new variety of strawberry (it’s Wimbledon season after all!). You develop it and the conclusion from your market research is that people like it! So you decide to try to sell it to a large supermarket. Now it needs to be better than your competitors, much better. Better on taste, better on price, as well as ensuring you’ve positioned your product in the right aisle. It’s not easy! The difference is in the product, strawberries compared to interventions, however both have the goal of ensuring patients get access to the best available option.

External article: Data Management Q&A - Stepping Back to Get the Big Picture

Written by PHASTAR on 22 June 2023. Posted in Blog

Phastar's Carly Baker, Director of Clinical Data Management, and Alice Wang, Principal Data Scientist, recently took part in a Data Management-focused Q&A for the ACRP's Clinical Researcher June 2023 release (Volume 37, Issue 3).

In a wide-ranging discussion the pair touch on the benefits of IDMCs in safeguarding participant safety and ensuring data integrity, as well as covering on the impact of decentralised trials and remote patient monitoring on data management, the selection of effective data collection methods, the utilisation of historical data for predictive analysis, the importance of data visualisation, and the challenges posed by differing international approaches to data regulations like GDPR. The Q&A session offers valuable insights for clinicians and researchers seeking to optimize their data management strategies and navigate the evolving landscape of clinical trials.

You can read the full Q&A at the ACRP website here.

AutoCRF: A tool to create a mock eCRF screen from excel data specifications

Written by PHASTAR on 21 June 2023. Posted in Blog

Case report forms (CRFs) are critical in clinical trials as they capture vital data related to patient safety, treatment efficacy, and overall trial outcomes. Good CRF design is essential to ensure the accuracy and completion of CRFs during the data collection process, warranting the validity and reliability of trial results and leading to the approval of new treatments and medicines. The design of electronic CRFs (eCRFs) for use in electronic data capture (EDC) tools is usually led by the data management team but requires input from various stakeholders, including the clinical team, statisticians and programmers to ensure the eCRFs capture all necessary data accurately and efficiently.

The data specification process for eCRFs typically involves creating an excel spreadsheet with specific columns and rows for each data element or ‘variable’ required for the study. These variables usually have specific definitions including data types, formats, range checks, validation rules, and other requirements specified in the study protocol. This excel spreadsheet of variables needs to be carefully reviewed by each stakeholder to ensure all required trial information can be collected easily and collection of any unnecessary or duplicate information is avoided. However, the review process can often be a challenge. It is difficult for some stakeholders from diverse backgrounds to visualise and easily interpret technical language written in the data specification file, and the overall process can lead to fatigue among reviewers. Insufficient review can result in later amendments to the eCRF which inevitably incur time and resource investment.

Celebrating the launch of Phastar Denmark

Written by PHASTAR on 17 May 2023. Posted in Blog

To celebrate the launch of Phastar Denmark, the company recently hosted a drinks reception for local partners and clients to come and meet the team. Situated in the Nordhavn area of Copenhagen, Phastar’s new location bolsters the company’s presence in the Nordic region and enhances its offering to local clients.

Guests were warmly welcomed by Scott McGregor, Phastar's Country Manager of Denmark, before receiving a series of presentations showcasing Phastar’s Data and Visual Analytics software and expertise.

Daniel Anderson, Director of Qlik Products & Extensions, performed a live demonstration of Phastar's versatile suite of user-friendly applications that enable fast clinical trial workflows, and seamless data integration from EDC to CTMS systems.