OUR SERVICES
Whether you need support for a full-service clinical trial or stand-alone services to support any phase of the drug or medical device development process, ACE CLINICAL has the expertise, knowledge and experience. Our consulting services address a wide range of therapeutic areas, and include services to support your clinical, regulatory, drug safety, medical affairs and training needs.
Clinical Development
Scientific and medical expertise:
Phase I to IV clinical studies - Study design and protocol development
Set up, conduct, analysis, reporting, publications.
Ongoing data review
Clinical study report
Regulatory submission - NDA, IND (EMEA, FDA, PMDA)
Clinical trial results disclosure - Clinicaltrial.gov
Investigator bronchure
Clinical development plan inc Pediatric investigational plan
Medical writing - Patient safety narratives
Quality Check (QC) of above documents
Medical Affairs
Advisory boards
Product Launch Support
Medical marketing support
KOL development
Promotional materials sign off
Medical Representative Training
Market access study design
Drug Safety & Pharmacovigilance
Medical review & Quality Check (QC) -
PSUR, DSUR
Safety Narratives
Risk Management Plan (RMP)
Summary of product characterisation (SmPC)
Individual Case Safety Report (ICSR)
Literature search
Review of AEs and SAEs reconciliation
Eudravigilance registration
Training and Development
GCP
Medical data Analytics
Statistical Series
Clinical Data Management
Clinical Pharmacology
Regulatory Submissions - FDA and EMEA