Approved Products | ACI Clinical

ACI’s services have supported more than 20 product approvals in many different therapeutic areas throughout our history. Projects have been conducted for top 10 global pharmaceutical companies, major academic institutions, and several biotech, medical device and diagnostics companies.

We are proud to have partnered with such an expansive client base and to have supported the following regulatory-approved products:

Product	Indication	ACI Services
Budesonide/formoterol fumarate dihydrate	Asthma and COPD	DMC
Varenicline	Smoking cessation	EAC
Teduglutide	Short Bowel Syndrome	Data Services
Donepezil HCI Drug delivery device	Alzheimer’s	Data Services
Alemtuzumab	Multiple Sclerosis	EAC
Afatinib	NSCLC	DMC
Dalfampridine	Multiple Sclerosis	DMC
Iontophoretic Drug delivery device	Pain	Data Services, Stats
Tiotropium bromide inhalation powder	COPD	EAC, DMC
Darbepoetin alfa	Breast cancer	Data Services
Defibrotide	Hepatic VOD	Data Services
Dimethyl fumarate	Multiple Sclerosis	EAC
Vitespen	Cancer vaccine	DMC
Methylphenidate	ADHD	Data Services, Stats
Tetrabenazine	Huntington’s disease	Cardiac Safety Advisory
Dronedarone	Atrial fibrillation (AFib)	DMC
Linagliptin	Diabetes	EAC
Computer-Assisted Personalized Sedation System	Anesthesiology	DMC
Lurasidone HCI	Schizophrenia	Stats, CDISC conversion
Epoetin Alfa	Anemia	DMC
Mobile Cardiac Outpatient Telemetry Diagnostic Monitor	Cardiac arrhythmia	Advisory Services, Data Services

“It is a testament to the excellent work of the team as well as the focus they showed in turning statistical analysis into two strong submissions with just one day turnaround to meet the deadline. There are many things we can't control in our business environment. But it's clear that we are taking control of those we can and driving for success.”

“I’m proud to be in this DMC Committee and I really thank you for fantastic cooperation. I’m impressed by your expertise & logistic handling of the study.”

“ I’m on a CEC for a another big organization and they aren’t anywhere near ACI; they’re a mess.”

“Thank You for your efforts, availability and prompt attention with the inspection requests related to CEC topics and particularly today with the adjudicated event clarification request! I agree that you have a great team. They are on things 24/7.”

“I know, that these are really exhausting weeks for you and would like to thank your whole team for your extraordinary job, your comprehension for spontaneous changes of the requirements and all your efforts to stick to our important timelines!”

“Thank you again for such quick resolution for this case. The ACI team organized and handled this so quickly and efficiently, and you certainly made DBL possible with minimal delay.”

“ACI has been superb. I think the process, the workflow, and the responsiveness is excellent. The ACI AIMS platform is one of the best I’ve used.”

“Clearly you as a team have given a lot to our drug approval and have worked as hard as anyone in support of the program. We learnt a lot and filled in more gaps.”