What We Are..!

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Your Trusted CRO…!

Regus, Level-2, Connaught Place, Bund Garden Road, Pune-411001, MH, India. Phone: 020-65-31-31-71 Email: [email protected]

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 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.

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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 top-class 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.

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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.

 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 to 10 years experience in the Pharmaceutical industry

 Highly experienced and receptive team

Our Team..!

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• I

n management of Global and domestic clinical trials

Precision and

perfection

•Project management, QA, QC, monitoring

Experienced Team

• Ability to adapt to fulfill sponsors/CRO requirements

Flexibility

• Faster Patient Recruitment & timely execution of project

Speedy execution

•Investigators and sites in different therapeutic areas

Large data base

• with study timelines, protocol and regulatory guidelines

Strict compliance

• Qualified, skilled and Experienced staff

Effective

communication

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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

6. 5. Medical Monitoring

7. Subject Management and Safety Management 8. Data Management

9. Quality Assurance & Quality Control.. etc

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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.

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Feasibility & Site Selection..!

Site

identification

Visit the

sites

Audit and

inspection

Feasibility assessment Report preparation Feasibility process is at the core

of our project

planning and proposal activity.

Our study feasibility

assessment process is efficient and is capable of identifying the best investigative sites to

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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

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Medical Monitoring..!

Trained in FDA regulations, ICH guidelines, and GCP/SOP compliance Strong monitoring and clinical experience Key therapeutic and specialty areas

Provide quality and performance feedback Provide study training and technical support at Sites Comprehensive SOP Trained CRAs

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Safety management..!

AE and SAE case receipt, coordination and

processing

Medical review of AEs and SAEs

Preparation of safety narratives

Perform expedited safety reporting

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

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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

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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

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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.

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Therapeutic Expertise..!

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

Ardent Clinical Research services deals with all major Therapeutic areas with India’s leading and potential Investigators.

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