Phases

Phase I

Karmic actively supports Phase I studies directly and through its global partners, highlights of our Phase I expertise as below

• Conducted Phase I studies in Oncology, Cardiovascular, Diabetes and Respiratory areas.
• Access to Phase I Clinical Pharmacology Units in US, UK, France, Germany, Belgium, Estonia, Romania and India.
• Sites with full ICCU set-up, experienced researchers with Phase I experience and 24/7 emergency interventionist support.
• Support for Pharmacokinetics and Pharmacodynamics Analysis for Phase I Protocols.

Phase II

Karmic has deep and specialist expertise in the conduct of Phase II Trials and Dosage Determining studies for safety and efficacy across several novel chemical entities and biologics across key therapeutic areas including Oncology, Cardiovascular, Diabetes, Neurology, Ophthalmology, Auto-Immune etc.

We have conducted over 15+ Phase II trials and support

• Protocol and Scientific Design for Phase II studies.
• Validation of Study Primary and Secondary End-points, Inclusion / Exclusion Criteria, Study / Laboratory Procedures, Schedule of Assessments etc.
• Validation of Bio-markers and Diagnostics to be incorporated in Protocol.
• Protocol Review & Validation from a Scientific Expert Panel comprising of Medical Doctors and Therapeutic Specialists.
• Site Feasibility and identification of investigators with strong Phase II experience and scientific orientation.
• Regulatory Submissions alongwith scientific rationale and justification and regulatory query management.
• Formation of a Clinical & Safety Oversight Panel for ongoing medical monitoring, review of safety data, trend analysis and clinical correlation of primary and secondary efficacy data, identification and analysis of outliers etc.
• End-to-end Study Conduct, Monitoring and Close-out, Coordination of Central Lab, Local Lab, IP Management and Trial Logistics requirements.

Phase III

Karmic has handled 30+ Phase III programs including multi-country programs involving 200-600 patients, highlights of our Phase III capability

• Protocol and Scientific Design and Validation for Phase III programs.
• Network of 100+ global sites directly and through our strategic partners in US, Western Europe, Eastern Europe and APAC to run multi-country, multi-site global programs.
• Global Regulatory Submissions alongwith scientific rationale and justification, ongoing regulatory query management.
• Global Trial Planning and Execution, unification of SOPs and Templates, Rapid Site Feasibility and identification of investigators with good OPD strength and patient recruitment capability.
• Complete Real-Time Trial Visibility through kTrials™ , web-based Karmic proprietary operational metrics dashboard.

Phase IV

Karmic has handled 15+ Phase IV programs and brings in strong field level experience in late phase trials and study specific strategies.

Our experience includes

• Handled large patient (1000+) multi-country (15+), multi-site (200+) programs with long follow-up periods (> 3 years).
• Experience across Observational, Post Marketing Surveillance, Registries, Additional Indication or Label Expansion, Comparative Effectiveness, Outcomes Research Trials.
• IRB/EC Management, IP Management, Rapid Trial Start-up and Close-out for Phase IV programs using global unified SOPs and Templates.
• Novel patient recruitment and retention strategies. (use of health camps, disease awareness programs, patient diaries etc.)
• Support on development of global physician and patient questionnaires, health assessment and quality of life questionnaires.
• Use of Electronic Data Capture, Tablet based Data Capture and ePRO (Electronic Patient Reported Outcome) tools for high quality data collection.
• Strong support from CDM on query follow-up and closure, rapid query closure and database lock, < 30 days of LPLV.