With an access to multiple Sites with hundreds of specialist Investigators and huge patient databases, we are equipped to conduct Sponsored Clinical Trials in an Effective, Reliable and Cost Efficient way.

We excel in all phases of Clinical Trials. Our clinical and project management teams provide integrated planning and implementation from start to end of any Clinical study. Our experience and services include (but not limited to):

• Large-scale global safety and efficacy studies
• Placebo-controlled studies
• Active-comparison studies
• Quality-of-life studies
• Resource utilization
• Individual study reports
• Integrated safety and efficacy summaries
• Package inserts
• Submissions in NDA or CTD formats
• NDA supplements
• Continuing Phase IIIb studies
• Post-approval regulatory commitments/ support for primary indication
• New indication studies/labeling expansion
• Product/disease registries
• Health-related quality of life, patient-reported outcomes via IVRS
• Post-marketing surveillance
• Retrospective chart reviews
• Managed-care studies
• Pharmacoeconomics

We have a team of experts in different fields who work together to ensure successful completion of sponsor trials. We have associate CRCs who have undergone formal courses in Best Practices, EDC, regulatory compliances and are experienced in diverse therapeutic areas. Each project team is headed by a project leader who manages and coordinates the activities of a multi-functional and distributed team.

Our controlled Processes and EDC Systems ensure high Quality and provide secured delivery of results to your door.

We have a team of experts who are experienced in effective diplomatic liaison with local regulatory bodies and help in the smooth conduct of Clinical Trials in India. We ensure timely turnaround of any documentation and consulted advice:

• Analyzing Protocol and determining regulatory formalities
• Preparing Trial Applications, Documentation and Dossiers
• Determining Export / Import license needs and channelizing execution in both countries
• Following up Documentation and Communication with regulatory authorities
• Assistance with IRB / EC processes and formalities

We ensure safe and legal movement, storage, usage, return and destruction of all Clinical Supplies. We have ICH compliant storage systems, Inventory management software systems and entrusted processes to ensure safe, legal and ethical prescription. For instance:

• Supply experts take care of export/import and Customs documentation work
• We perform random screening / interview of patient subjects
• We perform audits to reconcile inventory

We employ custom tailored recruitment strategy to hire patient subjects based on the protocol needs. While our liaison with various sites and its patient database is a big asset, we are not limited by it. Our programs ensure most ethical, speedy and effective recruitment process. For instance we evaluate factors like – Demographic distribution of population, current studies in place, Protocol requirements and Climatic conditions.

We provide Data Management services varying from paper based to completely paperless systems. Our highly skilled IT department creates and maintains custom tailored data capture systems (EDC) based on Industry standards and Open Source technologies. We train CRCs for managing data entries. We also provide a ‘Client View’ and/or customized integration of all research data with your Systems.

Our Data Management services are also available as stand alone services when you choose other CROs to host your trials.