Accelerating Biologics
Development with Confidence

Complex trials demand intelligent solutions

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In today's biologics development landscape, success demands more than just technology – it requires deep understanding of the unique challenges facing sponsors and CROs. From managing temperature-sensitive, expensive drug supplies to capturing high-quality patient experience data for regulatory submissions and value demonstration, every aspect of biologics trials brings distinct complexities.

That's where Signant Health's comprehensive eClinical solutions and services make the difference.

Why choose Signant Health? 

Our leading suite of solutions addresses the core challenges of biologics clinical development:

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Minimize investigational product wastage

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Our RTSM and GxP Inventory solutions deliver sophisticated planning and management of temperature-sensitive, expensive, short-expiry biologics – minimizing wastage and enabling accurate mid-trial planning, while ensuring optimal supply across all trial sites.

Capture highest-quality data

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Our eCOA solutions provide comprehensive capture of patient (PRO), observer (ObsRO) and clinician (ClinRO) reported outcomes data supporting efficacy, safety and immunogenicity endpoints – vital data supporting both regulatory decisions and value demonstrations for price negotiations under the Inflation Reduction Act (IRA).

Simplify participation in complex trials

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From rare disease studies to pediatric populations, our decentralized elements – including eConsent and TeleVisits – reduce participation barriers and enhance patient engagement.

Expert guidance

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With deep experience across autoimmune disorders, oncology, pediatrics and rare diseases, our scientific and operational teams provide strategic input from protocol development through study completion.

Biologics-Icon-Wastage

Our RTSM and GxP Inventory solutions deliver sophisticated planning and management of temperature-sensitive, expensive, short-expiry biologics – minimizing wastage and enabling accurate mid-trial planning, while ensuring optimal supply across all trial sites.

Biologics-Icon-QualityData

Our eCOA solutions provide comprehensive capture of patient (PRO), observer (ObsRO) and clinician (ClinRO) reported outcomes data supporting efficacy, safety and immunogenicity endpoints – vital data supporting both regulatory decisions and value demonstrations for price negotiations under the Inflation Reduction Act (IRA).

Biologics-Icon-Participation

From rare disease studies to pediatric populations, our decentralized elements – including eConsent and TeleVisits – reduce participation barriers and enhance patient engagement.

Biologics-Icon-Guidance

With deep experience across autoimmune disorders, oncology, pediatrics and rare diseases, our scientific and operational teams provide strategic input from protocol development through study completion.



MEETING TIMELINE COMMITMENTS

We understand that biologics development timelines are critical. Our proven track record of on-time delivery ensures your studies start and progress without delay. 

 
 




OUR EXPERIENCE IN BIOLOGICS TRIALS

Nearly 50% of Signant’s eCOA projects have been in support of large molecules. This number will continue to increase, particularly in CNS disease indications, where Signant has the richest history of supporting CNS trials compared to any other eCOA company. 
 

Ready to boost your biologics trial?

Get the competitive edge you need: Our eCOA solutions not only enhance the efficiency and quality of your trials but also support the robust value demonstration crucial in the post-IRA environment.