What We Are..!

Transcription

1 Your Trusted CRO! Regus, Level-2, Connaught Place, Bund Garden Road, Pune , MH, India. Phone: Web:

2 What We Are..! Ardent Clinical Research Services is one of India s leading providers of integrated clinical research services having operational facilities in Pune, MH, India. We serve to our clientele comprising of biopharmaceutical, Herbal, Neutraceutical, Device companies and generic drug industry with a broad spectrum of superior quality services. We are a team of highly qualified clinical research experts with extensive experience in offering a wide array of Clinical Research operations. Each one of our services is designed to meet our customers specific needs. We follow the ICH GCP, Standard Operating Procedures (SOPs) and all our clinical trial activities conform to the regulatory principles and guidelines. With our rich domain expertise and the exhaustive database of investigators, we consistently deliver faster patient recruitment, quick turnaround time, cost-effective trials and a world-class clinical support.

3 Our Working Principles..! The working procedures at Ardent Clinical Research Services are based on two-fold tenets but at the heart of these tenets, lie ethics, quality and the well-being of our patients and the clinical trial subjects. For our customers To fulfil all the present and prospective needs of our customers with our team s topclass talent, our state-of-the-art infrastructure and the cutting-edge systems. To associate and work with our customers in flexible partnerships with emphasis on qualitative delivery of services, affordable innovation and productivity. For other stakeholders To maintain the highest standards of ethics, patient-care and professionalism while dealing with patients, physicians and providers. To provide the employees with a sociable and safe work environment that inculcates scientific, managerial and leadership skills and fosters professional growth.

4 Our Team..! The team of experts at Ardent offers management and leadership solutions to clinical researchers to ensure that their project starts on the right foot. Apart from a timely start, an efficient execution and delivery of clinical trial projects is ascertained. We have.., Highly experienced and receptive team 5 to 10 years experience in the Pharmaceutical industry Experience with all phases of clinical trials in both paper and EDC environments Well trained and potential staff (ICH-GCP, ICMR, Schedule-Y and FDA regulations)

5 Our Strengths..! Precision and perfection Experienced Team In management of Global and domestic clinical trials Project management, QA, QC, monitoring Flexibility Speedy execution Large data base Strict compliance Effective communication Ability to adapt to fulfill sponsors/cro requirements Faster Patient Recruitment & timely execution of project Investigators and sites in different therapeutic areas with study timelines, protocol and regulatory guidelines Qualified, skilled and Experienced staff

6 Our SOPs..! Established procedures followed by us in carrying out a given operations: 1. Study Start-up, Site Feasibility and Site Selection 2. Site Initiation visit 3. Vendor Selection & Agreement 4. Protocol writing & development 5. Project Management Medical Monitoring 7. Subject Management and Safety Management 8. Data Management 9. Quality Assurance & Quality Control.. etc

7 Our Solutions & Offerings..! We hold extensive experience at managing every aspect of the clinical studies from Phase I to Phase IV including the post approval analysis thereof. Ardent Clinical Research Services avails every required provision to its customers to help them conduct successful clinical research. Our offerings include: Site Selection and Site Feasibility, Project Management, Medical Monitoring, Data Management Medical Writing, Safety Management, Regulatory Services, Site Management Services, BABE Analytical Studies, Herbal and Neutraceutical Studies. Our comprehensive services allow customers to select a personalized research plan to meet their needs.

8 Feasibility & Site Selection..! Feasibility process is at the core of our project planning and proposal activity. Site identification Visit the sites Audit and inspection Feasibility assessment Report preparation Our study feasibility assessment process is efficient and is capable of identifying the best investigative sites to conduct a clinical trial.

9 Project Management..! Therapeutic expertise from all appropriate functional areas Proactive management techniques and timeline control Proactive approach &close attention to client pain points and relieving their concerns by addressing by Risk Assessment and Mitigation Plan.

10 Medical Monitoring..! Key therapeutic and specialty areas Provide study training and technical support at Sites Comprehensive SOP Trained CRAs Provide quality and performance feedback Strong monitoring and clinical experience Trained in FDA regulations, ICH guidelines, and GCP/SOP compliance

11 Safety management..! AE and SAE case receipt, coordination and processing Provide- highly credible inputs for the design of comprehensive study specific safety management plans, to ensure AE s & SAEs are reported and processed accurately as per the regulatory guidelines Medical review of AEs and SAEs Preparation of safety narratives Perform expedited safety reporting

12 Medical Writing..! Medical Writing is an integral part of clinical research. Our Medical Writers have a wide range of knowledge and experience drawn from the pharmaceutical industry and clinical research organizations. All documents produced by Ardent Clinical Research Services undergo thorough scientific, statistical, editorial and quality control review. Medical Writing Services Includes : Design and preparation Study Protocols Investigator Brochures ICF design and translations in different languages CRF (paper and ecrfs) design Product monographs Report Preparation for clinical studies Pharmacovigilance documents such as Periodic Safety Update Reports

13 Data management..! Ardent Clinical Research Services provides end to end comprehensive clinical data management services to the clients from Data Management Plan to Database Lock. The team works on a robust portfolio and strives to ensure the highest quality. Clinical Data Management Services Include : Data Management Plan (DMP) development CRF/eCRF design and development CRF Completion Guidelines Database Build & Design Data validation specifications Data processing through double data entry Query Management Safety Data Management & Reconciliation Support of Phase I to post-marketing trials Provide Software s to the Hospitals SAS Programming and statistical Analysis

14 Regulatory Submission..! Regulatory services to facilitate all stages (Phases II-IV, BE and device studies) of drug development. Deep understanding of, and experience in dealing with the Indian drug control regulations. Complete study management and/or as customized services. Preparation, compilation and submission of regulatory dossier to DCGI.

15 Therapeutic Expertise..! Ardent Clinical Research services deals with all major Therapeutic areas with India s leading and potential Investigators. We expertise in following therapeutic areas: General Medicine Hematology Endocrinology Infectious Disease Gastroenterology General Surgery Oncology Cardiology Neurology Nephrology Psychiatry UTI and Pneumonia Orthopedic ENT Obstetrics & Gynecology Pediatric Herbal Research Neutraceuticals

16 Why Choose Us..!

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