CDISC legislation – is the wait finally over?

With the deadline for the implementation of CDISC standards fast approaching, we look at what this means for the industry.

​September 24, 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 It is simply not enough for companies to update their IT tools, as software can become outdated before it is implemented.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. ​

Posted over 8 years ago

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