Interview with Matilde Thye Kveiborg

Interview with Matilde Thye Kveiborg

“The documents that are produced by medical writing are key to fulfilling regulatory requirements. And they are also keys to successfully advancing a product’s development.”

Interview with Géraldine Mercier

Interview with Géraldine Mercier

“In data management, we are technical experts, we develop specific databases to collect and verify patient data according to the protocol approved by the health authorities.”

Aixial Group Migrates Specific Clinical Data Portfolio Onto Medidata Platform to Create a Single Source of Truth and Accelerate Database Lock

Aixial Group Migrates Specific Clinical Data Portfolio Onto Medidata Platform to Create a Single Source of Truth and Accelerate Database Lock

Leveraging Medidata solutions will enable the CRO to improve clinical trial experiences for patients and sponsors

Interview with Estelle De Bary

Interview with Estelle De Bary

“A Global Study Manager plays a crucial role in the clinical research industry as we are responsible for the smooth running of the entire clinical study.”

Interview with Valentina Zhukova-Harill

Interview with Valentina Zhukova-Harill

“The Chief Medical Officer plays a key role in ensuring that clinical trials are conducted ethically and on the highest level of patient safety.”

Interview with Ashley Hunter

Interview with Ashley Hunter

“Our mission is to always be an extension of our sponsor team and not act as a separate entity, a true partnership.”

Interview with Jules Morsch

Interview with Jules Morsch

“Working as a toxicologist in the pharmaceutical industry allows me to contribute to ensuring that patients around the world have access to safe medicines.”

How to prepare effective regulatory documents?

How to prepare effective regulatory documents?

Insights from Matilde Thye Kveiborg, Director of Medical Writing and Tanja Jensen, Senior Medical Writer

Demonstrating product value from multiple endpoints in rare disease trials

Demonstrating product value from multiple endpoints in rare disease trials

Rare diseases are often multifaceted, and a single endpoint is often not sufficient to fully describe treatment

Experts in Radiopharmaceutical Development

Experts in Radiopharmaceutical Development

Radiopharmaceutical therapy utilizes radioactive atoms to target and precisely treat cancer cells.

Mechanistic evidence by the HTA bodies

Mechanistic evidence by the HTA bodies

At the bottom of the EBM hierarchy, mechanistic evidence is not highly valued by the HTA bodies responsible for…

Indirect treatment comparisons

Indirect treatment comparisons

Lionel RIOU FRANÇA, Chief Scientific Officer, was involved in two analyses involving patients with Late-Onset Pompe…