Diverse Health Research Services

The Right Experience for the Right Job....

Whatever the possibility of your research needs, Med Pharma CRO provides the comprehensive clinical development service you requisite, from First time-in Human along the course of Phase IV and post-marketing surveillance. We also ensure regulatory expertise, clinical trial procedures management, financier and market access arrangement, medical learning and reports disseminations competencies to complete your journey proficiently and successfully.

As a contract research organization (CRO) we offer variety of services that are provided by reputed Scientists, Clinicians & Technical Support Staff for FMCG, Pharma, Health Supplement, Food & AYUSH Industries...

• Investigator’s Drug Brochure prepared specific to Natural Products. 
• Specialized Protocol writing skills. 
• Efficient Case Report Forms to allow Audit Trail. 
• Multilingual Consent Forms, high respect for Patient Safety and Rights. 
• Thoughtful Statistical Planning leading to achievable endpoints. 
• Efficient and well documented Trial Supply Management. 
• Elaborate Site Selection, Site Initiation and Investigators’ Meets. 
• GCP Trained, Experienced Investigators 
• Compliance monitoring by highly motivated and trained monitors 
• Timely Adverse Event and Serious Adverse Event Reporting 
• Direct Access to all site data allowing smooth GCP audit 
• Certified Central and Local Pathology Labs 
• Data Management using Clinical Oracle, Symmetric or DMSys. 
• Statistical Analysis using SPSS or SAS. 
• Medical writing by joint team of investigators, medical writers from multiple disciplines 
• Prompt and accurate Interim and Final Reporting 
• SOPs to ensure a QA System for Trial conduct and Data management 
• Manuscript writing and publication of study results 

Pharmacological Study Services...

• Proactive planning ensures efficient risk management before, during and after the study.
• Each study is run by a dedicated Study Director and conducted by toxicologists with the right qualification, training and experience.
• Independent quality assurance systems and checks guarantee consistent compliance with regulatory guidelines. 
• An audit trail ensures complete access to raw data generated during the study. 
• Efficient cold chain maintained with data logger if organs or tissues are called for after the study.
• Allied services like test item stability, impurity analysis and formulation development also available.

Scientific Writing Services...

• Complete Scientific Literature Search 
• Rational Formulation design and Ingredient selection 
• Dossier preparation for regulatory submissions  
• Dossier preparation for funding purposes 
• Preparation of Chemistry Manufacturing & Controls (CMC) Dossiers 
• Preparation of Investigator’s Drug Brochure (IDB) 
• Search & Consulting for Good Agricultural Practices (GAP) compliance 
• Search & Consulting for Botanical Drug Product IND submissions 
• Search & Preparation of promotional material, etc. 
• Ethnobotanical search on specific plants or plants for specific activities 
• Photos of Flora (aerial parts of live plants) and Herbal drugs of commerce

Quality Control Services...

• Standardization and Control of Herbal Actives. 
• Testing and Control of Impurities: Foreign matter, adulterants, Physico-Chemical analysis, Pesticides, Residual Solvents, and Microbial limits, etc. 
• Isolation and purification of marker compounds. 
• Ingredient Standardization and Testing. 
• Formulation Standardization.
• Battery of tests applied ranging from simple chemical assays to Chromatographic Analysis. 
• Method Development for Stability Studies and Pharmacokinetic Studies. 
• Trouble-shooting for Polyherbal Formulations. 
• Impurity profiling and characterization. 
• Accelerated Stability studies according ICH and other regulatory requirements. 
• Preparation of Chemistry, Manufacturing and Controls (CMC) Dossier. 
• Bioanalytical Method Development. 
• Quantitative analysis of ingredients in the formulation without using marker compounds.