Certara has agreed to acquire Pinnacle 21, which offers software for the preparation of clinical trial data for regulatory submission, for a cash and stock consideration of $310m.

Pinnacle 21’s portfolio consists of software tools that check for compliance with the Clinical Data Interchange Standards Consortium (CDISC) standards.

The US Food and Drug Administration and Japan’s Pharmaceuticals and Medical Devices Agency require the CDISC standards while China’s regulatory agency prefers them.

With the acquisition, Certara expects to play an important role in the data standardisation process throughout the drug development lifecycle.

Certara CEO William Feehery said: “The complementary acquisition of Pinnacle 21 marks an important expansion of Certara’s biosimulation and regulatory software and technology-driven services.

“The fuel for biosimulation, machine learning and statistics is high-quality, standardised data.

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“Pinnacle 21 is a leader in biopharmaceutical data fitness, which streamlines quantitative analyses needed by our clients. This addition to our business creates compelling opportunities as we integrate and expand our complementary offerings.”

Data standards are complicated and challenging to ensure compliance, due to the rise in trial data volume, along with the biopharmaceutical industry globalisation and the emergence of various health technologies such as wearables.

Effective and accurate analyses require quality, standardised data, Certara added.

The validation software of Pinnacle 21 generates reliable, compliant and quality datasets to mitigate the risk of regulatory delays, which can be expensive.

In addition, the datasets can help expedite new drugs to market.

Pinnacle 21 founder and CEO Max Kanevsky said: “Both companies empower customers to collect, validate, and analyse data to inform critical decisions in drug development and achieve regulatory success.

“Joining forces with Certara tightens the link between clean data and informed analysis.”

The companies will integrate and extend their software platforms to accelerate treatments’ availability to patients.

Approved by the boards of both companies, the acquisition is anticipated to complete in the fourth quarter of this year.