About Oleksandra Bystrova

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So far Oleksandra Bystrova has created 17 blog entries.

One Size Doesn’t Fit All: Why CRO Flexibility Matters More Than Ever

In today’s clinical development landscape, no two trials, or trial Sponsors, are exactly alike. Each organization brings its own needs, priorities, and operating models to the table. For this reason, outsourcing strategies for clinical trials can vary widely. Some Sponsors prefer to engage multiple specialized vendors, selecting only the services they need to complement their internal capabilities. Others opt for a single, full-service CRO to manage the entire trial, leaning on a unified partner for seamless execution.

By |2025-04-16T22:07:52+01:00March 25th, 2025|WEP Insights|

Early Access Programs (EAPs) in France: A Strategic Advantage for Pharma and Biotech Companies

Early Access Programs (EAPs) in France provide pharmaceutical and biotech companies with a valuable opportunity to offer patients innovative treatments before obtaining formal marketing authorization. Regulated by the French National Agency for the Safety of [...]

By |2025-03-06T16:44:24+00:00March 6th, 2025|Uncategorised|

The importance of a strong Clinical Monitoring team when collecting data in an EAP

Expanded Access Programs (EAPs) allow patients with serious or life-threatening conditions to obtain investigational treatments outside of the clinical trial setting. Because they are not formal clinical trials, EAPs do not require as much data [...]

By |2025-02-17T10:42:12+00:00February 17th, 2025|WEP Insights|

The need for Harmonized Regulations in the Expanded/Early Access, Compassionate Use and Named Patient Use space

Expanded/Early Access (EA), Compassionate Use (CU) and Named Patient Use (NPU) are critical pathways for patients with serious or life-threatening conditions to obtain investigational treatments outside of clinical trials. While these programs offer hope for [...]

By |2025-02-11T12:53:50+00:00February 6th, 2025|WEP Insights|