In the complicated process of drug development, approximately 70% of the costs are incurred in clinical testing. We believe that there is so much high-potential research with academia and industry that is not able to benefit humanity because of cost and time barriers and we want to change that. By offering affordable clinical trial management services we hope to increase research throughput. Currently we are focused on service offerings for:

• Phase III and IV Clinical Trials;
• Post-Marketing Surveillance; &
• Clinical Data Management.

Regulatory Affairs

• Preparation and submission of complete range of regulatory documents to IEC and DCGI
• Import of the drug
• Obtain permission to conduct clinical trial

Project Management

Through meticulous planning and co-ordination we strive to deliver projects on time and on budget with no compromise on quality, patient safety, and confidentiality.

• Recruit investigators through our direct contact and in-house investigator database
• Train investigators and site personnels
• Patient recruitment, education and retention
• Randomization, repackaging, coding and labeling of investigational drugs
• Schedule and conduct meetings: (audit sponsor, etc.)
• Clinical trial advertising
• Sponsor and IRB/IEC correspondence
• Clinical Trial Materials (CTM) management
• OpenClinica and dotProject is used for Project Management

Medical Writing

Our medical writers are focused on preparing clear, concise, and high quality documents, easy to read for regulatory approval, trial participants, investigators, and co-coordinators.

• Investigator Brochure
• Case Report and Informed Consent Forms
• Patient Information Leaflets
• Safety Data Reports
• Medical Translation Services
• Regulatory Submissions
• Final Report

Data Management

Building on our team's extensive IT background we integrate custom and 3rd party technology solutions to automate study design, data collection, data management and regulatory submissions.

• Electronic Data Capture (EDC)
• Drug Supply Management
• Database Reliability
• Project Management
• Remote Data Capture
• Adverse Event Reporting
• Data Validation and Quality Checks

Site Management

We work closely with investigative sites to help them achieve their full potential, and at global quality standards.

• Site identification, feasibility assessment and selection
• Site initiation
• Safety and Quality Monitoring
• Study Close-Out
• Query Management
• OpenClinica is used for site-managmenet

Safety and Quality Monitoring

PLS strives to surpass global standards of data quality and ensure ethical clinical trials. Through audits, trainings, SOPs, and technology we ensure safety and quality in the clinical trial process.

• Serious Adverse Event data collection, evaluation, classification and reporting to Central IRB/ Sponsor/ Regulatory Authorities
• Periodic quality & safety reports
• ICH-GCP compliance monitoring
• IRB & On-site investigator audits
• Drug accountability

PLS is better suited to meet your needs because :

• Patient recruitment: Our strategic network of investigators, clinicians and hospitals in India enables us to recruit patients for participating in trials at a significantly accelerated pace. Through us you get access to India 's wide population base of over one billion providing a great cross-section of many diseases and without much exposure to drugs.
• International Quality: Through our trainings and standard operating procedures we ensure full compliance to GCP guidelines as required by the regulatory authorities in US and EU.
• Cost: Through efficient processes and our strategic operation base in India we feel we can deliver cost savings of up to 50% to our customers in the US and EU, while maintaining excellent quality.
• Team: Our team comes from all aspects of the healthcare, economics and technology landscape encompassing more than 200 years of clinical research experience. Our advisory panel comprises of world renowned authoritative figures in the healthcare industry. Our execution team comprises of english speaking GCP trained medical professionals with excellent communication skills.
• Technology Infrastructure: We have set-up numerous web-based managements systems to provide you better visibility, feedback, and control on the trial. Since our US team is seasoned in the outsourcing model, our tools and processes are designed to make the experience enjoyable.
• Regulatory Approvals: Our India team has deep understanding of the clinical and regulatory issues involved for conducting trials for overseas companies.