BA/BE Studies

OFFERING FULL-SERVICE CLINICAL STUDY SUPPORT:

Actimus Bio provides the best full-service biopharmaceutical solutions to companies in the world, bringing together the best clinical and commercial minds to improve patient access to medicine. We offer a range of contract research organization (CRO) services executed by professionals fully dedicated to Clinical development.

Our services include:

• Protocol design and early phase concept and program development
• Protocol writing
• Regulatory and pre-IND/IND meeting consultation services
• Scientific consultation
• Multi-site feasibility support based upon established QA-approved site network
• Dedicated project management group
• Biostatistics and statistical design planning specific to clinical development studies
• Pharmacokinetics
• Clinical monitoring
• Pharmacovigilance
• Site management

CLINICAL PHARMACOLOGY STUDY EXPERIENCE:

• Bioavailability Studies
• Bioequivalence Studies
• Food Effect Studies
• PK/PD Studies
• Drug-Drug Interaction Studies
• 505 (B)(2) Studies

We have strong team handling BA/BE Studies in Healthy Volunteers with different dosage forms. We have conducted clinical studies on various dosage forms, which include: 

• Solid oral formulations [Tablets (Immediate release & modified release e.g. ER, DR, SR), capsules, soft gels, etc.]
• Parenteral formulations
• Topical transdermal products (Patches, Cream, Ointments, Solutions)
• Inhalation
• Nasal and oral sprays
• Rectal Products (Suppository & Foam)
• Vaginal products (Tablet)
• Long acting injectable
• Lozenges.

Our dedicated Volunteer data base management team maintains a Strong database of healthy volunteer pool.  

• Strong Data base of more than 10,000 healthy volunteers.
• Our pools includes all kinds of populations including females, post-menopausal women, Geriatrics.
• More than 50% repeat volunteers. 
• Minimal drop out % in replicate studies.