AXIS Clinicals 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.

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

ACROSS is the first truly global, agile CRO alliance. Offering cost effective, cutting edge innovative solutions for small/medium pharmaceutical and biotech companies as well as public health institutes and non-governmental organizations, ACROSS is the latest player on the global field of clinical trials.

ACROSS Global is an entirely new business model, providing enhanced and innovative global solutions through highly qualified, globally experienced, knowledgeable local experts. ACROSS Global identifies, analyses and mitigates risks across the entire clinical research spectrum, with an agility and focus to the envy of competitors. We provide value added solutions individually tailored for small and mid-size companies.

A consumer-led global pharmaceutical company, creating healthy doses of life since 1949.

When you operate in an industry like pharmaceuticals, your work goes way beyond creating ‘products for customers’. It is different from any other domain – there lies a higher sense of responsibiliti and a need for utmost integriti in everything you do. As you serve millions of lives, high qualiti standards become a pre-requisite, and safeti of your people and consumers always comes first. All this, while ensuring that each life you touch is treated with respect and digniti.

For more than 60 years, Ipca has been a crucial healthcare partner in over 120 countries across the 6 continents. We are a fully-integrated pharmaceutical company that manufactures over 350 formulations and 80 APIs for various therapeutic segments.

Today, we are one of the world’s largest manufacturers and suppliers of over a dozen APIs. These are produced from scratch at fully-automated manufacturing facilities, approved by the world’s most discerning drug regulatory authorities like UK-MHRA, EDQM-Europe, and WHO-Geneva, among others.

- One of the largest suppliers of these APIs worldwide with manufacturing leadership in over 12 APIs globally
- 15 APIs & 11 Formulations manufacturing facility across the globe
Leader in DMARDs (Disease Modifying Anti-Rheumatic Drugs) treatment for Rheumatoid Arthritis
- Leading brands in Pain, Rheumatology, Antimalarials and Hair care therapy
- 4 formulations rank amongst the top 300 brands of IPM as per IQVIA

TRIUMPHARMA was founded in 2002 , is a full service CRO that supports the pharmaceutical and the biotech industries in introducing new solutions to the pharmaceutical markets, with core strength in :
Clinical Trials [Phase I - Phase IV] including Clinical Data Management and BE/BA studies.

Over the years we have successfully conducted more than 300+ US-FDA submissions , EU/ANSAM/Bfarm/MHRA submissions (NDAs & ANDAs) and MENA/JFDA submissions, using HVs and patients in various therapeutic areas such as CV diseases, Gastro-intestinal disorders, Respiratory/Pulmonary disorders, Metabolic disorders, Endocrinology, Nephrology/Hepatology, Rheumatoid Arthritis Disorders of immune systems, Neurology/Psychiatry, Gynecology, Acute/Chronic infections and Oncology.

TRIUMPHARMA has experience in many of the POC indications, in addition to our experience in early phase studies such as Asthma, NASH, Parkinson, AF, Diabetes, and others. We have also conducted many studies on monoclonal antibodies including HAE and biosimilar /biotech products.

TRIUMPHARMA encompass a total bed capacity of 80 beds across our two floors ((over 200 beds with our hospital sites) and 5 LC/MS/MS machines. We have a dedicated facility and team for Phase I-IV clinical trials conducted in compliance with ICH GCP guidelines. And we have our own diagnostic and screening medical lab, Bioanalytical lab with state of the arts LC/MS/MS equipment’s, the trained PIs, Research Nurses, CRCs, CRAs, Project Management, certified and trained Spirometer technicians, dedicated Data Entry team with familiarity with the relevant and most updated clinical software’s used in trials, Qualified site and IMPs Depot .We are also able to offer our clients the benefit of a large collective experience when formulating and implementing regulatory strategies and study designs.

We have successfully been inspected by US-FDA , EMA, French Ministry of Health-ANSM, German Ministry of Health- Bfarm, Turkish MOH, GCC, UAE MOH, JFDA,