our Services

Program design and implementation

• Study design (study protocol preparation and review)

• CRO selection (identification and assessment)

• Preparing CRO Master Serice Agreements (MSAs) and agreeing study costs

Study specific support

• Study monitoring - reviewing critical phases of the studies

• Data review - evaluation of cardiovascular safety data

• Report reviews

Due diligence activities

• Gap analysis of pharmacology and toxicology data.

• Preparing summary reports and presentations for out-licensing/partnering discussions

Regulatory support

• Preparing IMPDs/CTD (NCO-Non Clinical Overview) & Investigator Brochures (Europe & US)

• Preparing Toxicology written and tabulated summary preparation for IMPDs/INDs/CTAs.