What we will do

When there is a problem or gap, we will become your long-term partner and create a way together to resolve the issue.

 

Why are we so confident?

Our oncology teams are known for integrating seamlessly with our clients to design product strategies and plans from translational science through to registration and medical affairs, worldwide. Whether your products target solid tumours or haematological malignancies, we will be able to help.

tranScrip has a proven track record of achievements that include:

Designing and delivering large, complex, cross-functional oncology programmes.

Preparation of development strategy, design of Phase II/III studies and regulatory interactions for an immunotherapeutic.

Serving as the “one-stop shop” drug development organisation for small biotech companies.

Providing clinical development and regulatory affairs team to support a HDAC inhibitor programme in prostate cancer.

Interpreting ‘difficult’ outcomes in clinical trials and steering discussions with the regulatory authorities.

Data interpretation and regulatory interactions to support MAA and NDA for a modified cytotoxic which failed primary endpoint in Phase III.

Fielding multi-functional submission teams to author and deliver MAAs and NDAs.

Pivotal trial reporting and full dossier preparation for targeted therapy in solid tumours.

Providing management and oversight for all drug safety needs.

Assessment of drug-drug interactions and risk profile for potential toxicity for combinations of PI3K inhibitors.

Support to product launch and lifecycle management.

Providing medical affairs support for VEGF TKI in renal cell cancer.