Eco Scientific Co., Ltd.

CliniRx is a global Clinical Research Organisation with deep regional experience. CliniRx offers ICH-GCP compliant clinical trial services from Phase I – IV in key therapeutic areas to support clinical development requirements. We have offices and operational capabilities in India, US and UK.

We offer end to end services starting from conduct of Feasibility Studies, Study Planning to Regulatory Submissions, Site Evaluation and Selection, Site Monitoring, Project Management, Medical Monitoring, Pharmacovigilance, Clinical Data Management, Data Analysis, Medical Writing and Quality Assurance.

INTOX - A premier Indian toxicological Contract Research Organisation (CRO), OECD GLP Certified by The Netherlands and the Indian GLP Monitoring Authorities. INTOX operates in the areas of toxicology, mutagenicity, environmental toxicity, chemistry and biologics. Since 1995 in business. Located in outskirts of Pune, India. Easily reachable from Mumbai and connected by airport connecting to all major Indian cities, with direct flights to Dubai and Frankfurt.
Meet INTOX representatives at CAC- Shanghai and SOT - USA in March.

COMPANY
Monitor CRO was founded in İstanbul (1999), as a pioneering Contract Research Organization in Turkey. We are currently the leading, most experienced and dedicated CRO with a 100+ full-time personnel with on-going monitoring activities for various international and national studies.
CLINICAL TRIALS & CONSULTANCY SERVICES
MEDICAL CONSULTANCY
• Clinical trial planning and design
• Recommendations for future studies/development
• Regulatory strategy identification
TRAINING
• Basic medical training
• Clinical trials trainings
• Good Clinical Practice (GCP) training for study monitors, investigators, research staff and site coordinators
MEDICAL WRITING AND SUBMISSION
• Protocols
• Case Report Forms
• Abstracts
• Trial documentation and archiving
• CRF, eCRF and ICF translations into local language and adaptation to local requirements
• Study reporting in line with ICH-GCP requirements
• Study Design and creation of Study Synopsis
• Manuscript writing
DATABASE MANAGEMENT
• Database Design
• Data Collection and Entry
• Drafting and Finalization of Data Management Plans
• Data Validation Cleaning and Query Writing and Handling
• Electronic Data Handling
• Medical Dictionary Management and Medical Coding
• SAE Reconciliation
• Quality Controls
• Statistical Analysis
PROJECT MANAGEMENT
• Observation
• Bioequivalence
• Phase I, Phase II, Phase III
REGULATORY AUTHORITY APPLICATIONS AND APPROVALS
• Initial Application, preparation for Ethics Committee
• Initial application file preparation for Regulatory approval
• Follow-up of applications
• Preparation of files for regulatory and administrative changes during study
• Pharmacovigilance reporting to EC’s and Regulatory Authority
• Applications to RA for site coordinators
• Institutional review board
SITE OPERATIONS
• Site selection and feasibility
• Site contracts and agreements
• Site monitoring
• Site coordinator outsourcing
PHARMACOVIGILANCE SERVICES

PHARMA-STATS (PS) is a statistical consultancy service provider primarily focused on the formulation development, design, analysis and reporting of data from clinical trials and post-marketing surveillance with bioequivalence studies. As experts in statistical solution provider, PS provides high-quality teams that offer efficient outsourcing solutions for:

• Biostatistics
• R/SAS Programming
• Statistical Consultancy for Formulation Development
• End to End Solution for Regulatory Statistical Query Response
• Data Safety Monitoring Board (DSMB)
• Various stage of Biostatistical Training to Industry Professionals and fresh Post Graduates

PHARMA-STATS can offer study level support, small level functional service provision (FSP), strategic full data-services solutions or technical consultancy to meet the needs of pharmaceutical, biotechnology and device companies across the globe. PS has become the supplier of choice for many manufacturers and sponsors companies from top tier pharmaceutical giants through to the UK to India. Our number one priority is ensuring on-time, quality work. Every project undertaken is supervised on methodology and internal QC processes.

PS also support pharmaceuticals, CROs to reach out to permanent and contractual statistical and programming staff.

PHARMA-STATS is known as Single Point Statistical Solution Provider for Pharmaceuticals and Medical Devices.

WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable companies in the pharmaceutical, biotech and medical device industries worldwide to advance discoveries and deliver groundbreaking treatments to patients. As an innovation-driven and customer-focused company, WuXi AppTec helps our partners improve the productivity of advancing healthcare products through cost-effective and efficient solutions. With industry-leading capabilities such as R&D and manufacturing for small molecule drugs, cell and gene therapies, and testing for medical devices, WuXi AppTec’s open-access platform is enabling more than 4,100 collaborators from over 30 countries to improve the health of those in need – and to realize our vision that "every drug can be made and every disease can be treated."