Clinical Research Services

LEADS have handled more than 40 Clinical trial projects in the last 3 years. It includes phase I to phase IV studies, Bio Equivalence studies, Bioavailability studies, Nutraceutical studies, Cosmetic studies and Observational studies.

We develop and maintain subject and volunteer database in different centres across India. It include database for healthy volunteers, post menopausal females, Asthma patients, diabetes patients, Hypogonadal males etc.

Our Clinical Research Services Include :

• 1. Protocol Designing
• 2. EC Submission and Approval
• 3. Site feasibility analysis
• 4. Investigator selection
• 5. Site Management
• 6. Site Monitoring
• 7. IP management and accountability maintenance
• 8. Regulatory Approvals
• 9. Data Entry and Data Management
• 10. Source Data verification
• 11. Statistical analysis
• 12. Clinical study Report

Medical Writing Services

1 Clinical Study and Regulatory Documents Writing

• 1. Clinical study outline
• 2. Clinical study Protocol
• 3. Informed consent form and patient information sheet
• 4. Clinical study report
• 5. Case record form
• 6. Site training manuals
• 7. Medical monitoring manual
• 8. Investigators Brochure
• 9. Electronic Common Technical Document (eCTD)
• 10. Development safety update reports
• 11. Review of SAP and TLF
• 12. Summary documents for regulatory submissions
• 13. PV documents: PSUR, DSUR, PBRERS

2 Medico-Marketing Writing

• 1. Monographs
• 2. Package Inserts
• 3. Patient and physician education material
• 4. Product Advertising
• 5. KOL development and interaction

GMP/FDA Compliance & Industry Automation

• 1. Pharma CGMP/FDA compliance Solutions
• 2. Pharma automation solutions
• 3. Pharma infrastructure automation