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…

For a reasoned therapeutic revolution in cell and gene therapy…

For a reasoned therapeutic revolution in cell and gene therapy…

Cell and gene therapies are multiplying, and with them the hopes of patients, their families, and healthcare professionals…

Cmed and Larix fully integrate into Aixial Group, the CRO solution of ALTEN GROUP

Cmed and Larix fully integrate into Aixial Group, the CRO solution of ALTEN GROUP

Cmed and Larix fully integrate into Aixial Group Press release – May 30th 2023 Following its acquisition of Larix in…

Rare Diseases: Phase I

Rare Diseases: Phase I

This case study looks at the challenges that arose in a Phase I First In Human trial for the progressive Wilson’s Disease

Cell & Gene Therapy: Safety and Clinical Activity in Patients with Relapsed or Refractory Diffuse Large B Cell Lymphoma

Cell & Gene Therapy: Safety and Clinical Activity in Patients with Relapsed or Refractory Diffuse Large B Cell Lymphoma

Cell & Gene Therapy: Safety and Clinical Activity in Patients with Relapsed or Refractory Diffuse Large B Cell Lymphoma Case…

Rare Diseases: Phase II Pediatric Study with Selected Metabolic Disorders

Rare Diseases: Phase II Pediatric Study with Selected Metabolic Disorders

Rare Diseases: Phase II Pediatric Study with Selected Metabolic Disorders Case study Aixial Group is currently working on a Phase…

Data Science & Analytics: Combining A Phase I Study with an On-Going Observational Arm

Data Science & Analytics: Combining A Phase I Study with an On-Going Observational Arm

Data Science & Analytics: Combining A Phase I Study with an On-Going Observational Study Case study This case study looks…

Early Phase Oncology: First-In-Human Study Of An Antibody-Drug Conjugate In Breast Cancer

Early Phase Oncology: First-In-Human Study Of An Antibody-Drug Conjugate In Breast Cancer

Early Phase Oncology: First-In-Human Study Of An Antibody-Drug Conjugate In Breast Cancer Case study For a First In Human study,…