CDISC legislation – is the wait finally over?

24 September 2015

For those within the industry, the debate on when CDISC standards will materialise has been ongoing for a number of years. Although such discussions are still taking place, it is rumoured that mid 2016 could be the deadline for all clinical and non-clinical data to meet CDISC standards upon submission across Europe.


With the number of new legislation and regulations already announced, our life sciences practice has been busy working with clients and candidates to help them adapt. In fact, the New Year already looks set to be very active.


With the proposed implementation of CDISC standards, such new regulatory changes will be positively welcomed across the industry. Standardised reporting will enable a more structured, clearer and precise detailed process that will explain the scientific results, as well as increase transparency and improve understanding from all invested parties.

Current process


Prior to CDISC standards, data is submitted in different formats according to the company, and the trials and projects. In return, the reviewer for each document undergoes a strenuous task of understanding and interpreting the data. As a result, pharmaceutical companies are forced to spend an extensive amount of time and money clarifying data and translating it into a comprehensive format that can also be understood by internal and external stakeholders.

What’s the solution?


To meet ever-changing legislative requirements, clients will need assistance with hiring CDISC consultants to ensure they continuously comply with regulatory standards. It is simply not enough for companies to update their IT tools, as software can become outdated before it is implemented. To be compliant, companies need to work with experts who have in-depth knowledge of industry standards, can reformat data to meet CDISC standards and have experience of converting other specific types of data.


This requirement is also applicable to regulatory agencies that can also set their own industry standards, which can sometimes conflict with CDISC. Therefore, CDISC consultants will ensure a company’s system is continuously aligned with different industry developments.


For example, clients overseeing large clinical development projects need to decide on the best way to manage data that meets CDISC compliance, whilst simultaneously gathering data from different studies that will also meet set requirements.

How we can help you


Preparation is key and as a proposed date has been announced, pharmaceutical companies will now need the relevant CDISC expertise to ensure they are compliant with new legislation.


To help clients better prepare, Hydrogen is utilising its long-standing global network of experienced CDISC consultants and niche CROs to share their knowledge with clients’ existing teams of programmers. We have created a training workshop that enables our consultants to train our clients’ staff on-site.


By doing so, clients have a dual solution that enables them to get their systems up to current standards to complete projects and implement a long-term solution that will see their staff keeping abreast of new legislation by applying their newly-gained knowledge.


To discuss how Hydrogen can help your company get ready for next year’s legislative change or if you are a professional seeking a new opportunity, please contact us to pre-book a free CDISC consulting session. Alternatively, we will be exhibiting at this year’s PhUSE in Vienna, so please visit stand 31 to discuss your CDISC requirements. ​

Project RPO, SOW, and MSP: choosing the right workforce strategy for your business
by Tina Ledger 19 June 2025
Project RPO, SOW, and MSP: choosing the right workforce strategy for your business
Doing More with Less – The GC Challenge of 2025
by Tina Ledger 12 June 2025
Doing More with Less – The GC Challenge of 2025
Empowering Women in the workplace: A conversation with Sasha Mauu
by Tina Ledger 9 June 2025
Empowering Women in the workplace: A conversation with Sasha Mauu
How SOW solutions drive project success
by Tina Ledger 19 May 2025
How SOW solutions drive project success
How Project RPO can solve your biggest recruitment challenges
by Tina Ledger 12 May 2025
How Project RPO can solve your biggest recruitment challenges
The rise of skills-based hiring
by Tina Ledger 7 May 2025
The rise of skills-based hiring
by Tina Ledger 28 April 2025
How AI is reshaping workforce management and how we can help you stay ahead
by Tina Ledger 27 March 2025
We're back! We're thrilled to announce the return of our interview series, Women in Law, where we shine a spotlight on the extraordinary women making waves in the legal world. Join us as we delve into their journeys, explore their challenges and triumphs and celebrate their remarkable achievements.
by Charlie Sell 25 March 2025
There’s a quiet revolution happening in the legal sector, and AI and data are powering it.
by Cameron McCammon 26 February 2025
With over 20 years of experience in the global legal arena, we've provided our clients with access to top legal talent worldwide. Leveraging our extensive industry connections and in-depth expertise, we've curated the most comprehensive salary data and hiring trends for professionals like yourself. Our 2025 Salary Guide provides an overview of competitive packages and explores the latest hiring trends shaping the landscape of Legal employment in your region. Get your complimentary copy of the 2025 Salary Guide directly to your inbox by filling in the form below.
More posts