Phase III trials
Smooth Drug Development provides a full range of services for conduct of large multi-center phase III clinical trials.
Phase III are planned for obtaining of Marketing Authorization after the drug has shown proven safety and efficacy in small groups in phase II and optimal doses and administration regimens are determined.
Phase III studies are divided into registration and post-registration:
Phase IIIa – confirmatory studies involving a large population of patients (as a rule, from 300 to several thousand). Phase IIIa trials are designed to statistically confirm safety and efficacy of the drug for a particular indication. Based on the results of the phase IIIa study Sponsor makes a decision regarding submission for Marketing Authorization of the drug.
Phase IIIb – studies that are conducted to collect additional data for the purpose of registration of new indications of the drug, dosage and dosing regimens, routes of administration, new dosage forms and additional age groups. Based on the results of the phase IIIa study Sponsor makes a decision regarding submission for Marketing Authorization of change of Patient leaflet of the drug.
We maintain business relationship with a number of partner investigational sites working in most common nosologies, which have proven their ability for rapid recruitment and providing of high-quality data and documentation.
If necessary, we involve our network of referral clinics, provide sites with trained personnel for non-medical work, as well as help to obtain necessary approvals and training for naïve sites which have rare target patient populations.
In general, to obtain regulatory approval for phase III study the following documents are required:
- Information on the composition of the drug
- Certificate of Analysis
- Reports of clinical trials in phase II
- Clinical development program
- Draft package insert
- Investigator's Brochure
- Clinical Study Protocol
- Information for subject and Informed Consent Form
- Information on compensation for subjects
- Other materials for subjects
- Insurance agreement for study subjects
- List of investigational sites and CVs of principal investigators
- Confirmation of application fees
- Clinical study feasibility
- Essential documents development
- Submission to Regulatory Authority
- Site selection and contracting
- Preparation of the central laboratory
- Preparation of sites for the study
- Programming and validation of databases
- Investigator’s Meeting
- Obtaining regulatory approval for the study and import/export
- Logistics of investigational products and materials
- Obtaining of approvals of Local Ethics Committees
- Site initiation
- Clinical monitoring
- Medical monitoring and pharmacovigilance
- Data management and statistical analysis
- Quality audit
- Development of the final report
- Site closure