Spectrum Oncology Pvt. Ltd.
71, Free Press House
Free Press Journal Marg, Nariman Point,
Mumbai - 400021,
Maharashtra, India

Capabilities & Experience

Capabilities

  • Pharmacovigilance
  • Data Management
  • Medical Writing
  • Protocol Development
  • Development of associated documents: ICFs, CRFs, Diaries etc
  • Site Selection and Monitoring
  • Study Drug Management: Blinding, Packaging, Distribution etc
  • GCP and study-specific Training
  • Statistical Analysis
  • Consultation on any of the above research activities.

Experience

  • Our operations team brings more than 100 years of combined experience in clinical research
  • We have performed molecule assessment in various therapeutic areas, comparative analysis with current therapeutic options and pipeline molecules with suggestions on possible design options for an efficient POC study and market analysis
  • We have developed SOPs and working processes for conduct of clinical studies
  • We have conducted feasibilities in various therapeutic areas for approx. 100 studies
  • We have designed and developed protocols and associated study documents (protocols, ICFs, CRFs, diaries, reports for publication)
  • We have managed, mentored, and trained a number of clinical research professionals
  • We have assisted in addressing the unique challenges associated with psychiatric studies such as subjective assessments, inter-rater reliability, scale validation and placebo response rates
  • We quickly adapt to meet project needs at every step with full-scale programs or recommending specific services for unique protocols
  • We have access to a strong network of Indian resources that provide reliable access to unique populations and qualified experienced investigators
  • We have managed vendors and provided oversight for the management of the below-listed activities for study
    • Drug Packaging
    • IVRS
    • Central Lab – Hematology, Biochemistry, ECG, PK etc.
    • Data Management
    • Pharmacovigilance Activities
  • We have experience in crisis management of ongoing programs by identifying the problem areas and suggesting solutions

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