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Phase II-IV Clinical trials:

SCR has vast experience in conducting Phase II - IV clinical trials for pharmaceutical, biotechnology and medical device companies. We have a team of experienced and trained monitors headed by a Project Manager & our monitoring services are governed by well defined SOPs and monitoring plans for each study.

SCR offers the following services:

  • Consulting
  • Protocol Writing
  • Informed Consent Form Writing
  • Preparation of Study documents (such as Case Report Forms, Diaries)
  • Regulatory Affairs / Clinical trial authorization
  • Recruitment of patients or study sites
  • Monitoring
  • Biometrics
  • Patient based pharmacokinetic studies
  • Presentations at seminars and congresses
  • Preparation of Publications (Manuscript and abstract Formation)

Project Management:

Project managers are a key for the successful completion of any clinical trial. SCR's project management team comprises of highly medically trained and experienced personnel. They strive to deliver projects on predefined time and on budget with no compromise on quality, patient safety, and confidentiality. During the course of trial planning and monitoring, clinical project managers strongly believe in maintaining honesty and transparency with our clients by regularly updating our clients on the progress of the projects.

The project manager ensures:

  • Planning and Directing project management strategies for timely deliverables and ensuring quality in predefined budgets.
  • Managing contractors including clinical research sites, CROs, central laboratories and external consultants
  • Recruit and Train investigators and site personnel
  • Patient recruitment, education and retention
  • Consolidation of data and project information and dissemination to the appropriate personnel
  • Schedule and conduct meetings: (audit sponsor, etc.)
  • Clinical trial advertising

Medical Writing:

Well written clinical trial documents are critical to getting your product to market. At SCR, team of efficient and experienced medical writers with scientific expertise to provide our client with documentation that will help to realize their regulatory and marketing goals.

SCR team excels in providing quality data with quick turn around time.SCR offers the following Medical Writing Services:

Pre-submission documentation:

  • Case Report Form
  • Clinical study protocol
  • Investigator brochures
  • Patient informed consent forms

Post-submission documentation:

  • Clinical study report (CSR)
  • Integrated summary of safety and efficacy
  • Common technical documents (CTD), other formats
  • Phase I-IV integrated clinical statistical reports (ICSR)

Scientific / medical communication:

  • Literature reviews
  • Slide presentations
  • Posters, abstracts, and manuscripts
  • Presentations
  • Educational material
  • Marketing and training material

All our medical writing services are compatible with ICH guidelines and other regulatory requirements. We guarantee high quality services in a timely fashion and according to your company standards (e.g. standard operating procedures, study guidelines, document templates). SCR is truly a one-stop solution for all your documentation needs.

Data Management:

Coming Soon….!