ClinSync
  • Home
  • About Us
    • Core Competencies
    • Vision and Mission
    • ClinSync Values
  • Services
    • Oncology and Special Population services
    • Early Stage Clinical Development
      • Brief Overview
      • Cardiac Safety/ TQT studies
      • Facilities in General
      • Phase I
    • Late Stage Clinical Development
      • Brief Overview
      • Data Management
      • Site Management & Monitoring
      • Program, Project & Study Management
      • Temporary Staffing/Flexible Sourcing Solutions
    • Bioanalytical Services
    • DMPK Services
    • Toxicology
    • Medical Writing
    • Biostatistics
    • Quality Assurance & Regulatory Services
    • Pharmaco Vigilance Services
  • International Operations
  • Collaborations
  • Career
  • Contact
  • Search
  • Menu

ClinSync

Our Medical and Scientific Affairs team renders medical writing, an advisory and monitoring support throughout the development program. We can suggest the most efficient way to design and conduct your development program to maximize success during all phases and offer to develop most effective clinical investigational plan for your clinical trial. Our expert medical writers are very well molded for clinical documentation thus ensures clear, concise and scientifically accurate Clinical Study Protocols, Investigator’s Brochure, Clinical Study Report. The clinical documents are thoroughly reviewed by highly qualified team members from relevant departments. Our medical writing team has vast experience in many therapeutic areas including Oncology, Psychiatry, Dermatology, Respiratory Diseases, Endocrinology, Nephrology, Neurology and Cardiology.

The highly experienced team of clinicians and scientists extend their in-depth knowledge to the project management team and investigative sites for medical and scientific queries related to the clinical study.

Services

  • Development of Protocol, Informed Consent Form (ICF) and Case Report Form (CRF) development
  • Preparation of Clinical Report, Analytical Report and Statistical Report
  • Adverse event and concomitant medication reporting using MedDRA and WHO-DD dictionaries
  • Preparation of FDA Summary Tables for ANDA Submissions
  • Development of medical investigational reports, regulatory affairs reports
  • Preparation of annual safety reports, individual case safety reports, Periodic safety update reports
  • Preparation of preclinical study reports, investigational medicinal product dossiers, toxicology reports, submission of IND and ANDA applications

End to End Services Includes

Oncology

HIV/ TB/ Malaria/ Hepatitis and other infectious conditions

Post menopausal women

Dermatology- Transdermal patches, Gel/ Foam/ Cream, Cumulative Irritation studies & Skin sensitization studies

Hepatic Impairment

Renal Impairment (at partner Kidney Center)

Hypogonadal studies

Contraceptive studies

Cardiovascular and Metabolic Diseases- Cardiac Failure & Diabetes

  • Bioanalytical Services
  • Biostatistics
  • DMPK Services
  • Early Stage Clinical Development
    • Brief Overview
    • Cardiac Safety/ TQT studies
    • Facilities in General
    • Phase I
  • Late Stage Clinical Development
    • Brief Overview
    • Data Management
    • Program, Project & Study Management
    • Site Management & Monitoring
    • Temporary Staffing/Flexible Sourcing Solutions
  • Medical Writing
  • Oncology and Special Population services
  • Pharmaco Vigilance Services
  • Quality Assurance & Regulatory Services
  • Toxicology
Scroll to top