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
- Clinical monitoring
- 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)
- Nasal and oral sprays
- Rectal Products (Suppository & Foam)
- Vaginal products (Tablet)
- Long acting injectable
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.