• info@orcirrus.com
Services
CLINICAL DEVELOPMENT

At ORCIRRUS we provide services to organisation with access to specialised service, you can leverage the time zone differences which means that you get a quicker turnaround in addition, our trained talented highly technical staff ensure that you always get quality service. As our partner, our focus is on understanding your requirements and translating this into customised solution. 

We specialise in the health care project management and project delivery activities. At ORCIRRUS, we can help support with our comprehensive clinical development services including,

CLINICAL TRIAL ADMINISTRATION

We offer comprehensive clinical trial administration services to successfully complete your trials – helping you bring new products to market safely and quickly.
  • Project management
  • Clinical trial monitoring
  • Study design and protocol writing
  • Clinical site evaluation and selection
  • Clinical site management

PHARMACOVIGILANCE

We provideexpertiseon pharmacovigilance services for clinical development includes.


  • Case processing and reporting

  • Aggregate Safety Reports preparation

  • Risk Management Plan preparation
  • Aggregate safety Update reports includes Development Safety Update Report (DSUR), Periodic Benefit Risk Evaluation Report (PBRERs) 

CLINICAL DATABASE PROGRAMMING SOLUTIONS

We specialize in database programming utilizing the latest EDC tools. Our service includes, database design, build and edit checks programming utilizing client standards or the global library. We help support lab setup and dictionary coding activities. The support includes start up, maintenance until study lock. 

SDTM PROGRAMMING

ORCIRUS adhere to the standards of CDISC which helps in simplifying the datasubmission to the responsible authorities.

We provide extensive SDTM mapping solutions compliant to CDISC Mapping of studies from legacy to CDISC standards Automated Submission data packages for regulatory submission

BIOSTATISTICS SOLUTIONS

ORCIRUS is a global provider of statistical and analytical services for clinical research and pharmaceutical industry. ORCIRUS places a keen focus on the early phase I studies and proof of concept studies, Phase I-IV clinical trials, bioequivalence and PK/ PD studies. Our biostatisticians have experience of managing simple to highly complex Phase I to IV clinical trials.

Our biostatistics services are tailored to meet your intensive research requirements.

  • Protocol and study design
  • Sample size calculation
  • CRF design inputs
  • Randomisation and blinding
  • Comprehensive statistical analysis plan and specifications
  • Statistical analysis and modelling
  • Support for clinical study reports and regulatory filing
  • Manuscript and other scientist paper publication support

Our expert biostatisticians support early phase clinical pharmacology trials for non-compartmental and compartment PK modelling of single and multiple dose studies , design and analysis of Dose proportionality studies, individual and population OK modelling

STATISTICAL PROGRAMMING

Our expert programmers have detailed knowledge of all Phases of clinical trials and experience of working on multitude of therapeutic areas across the drug development program

Our statistical programmers seamlessly support for clinical development program to deliver high quality deliverables on time, and provide flexibility to meet your desired amount of resource in accordance with your development programs.

Our statistical programmersare equipped with,


  • SAS and R programming for Analysis Datasets and TLFs and Quality Control for clinical studies and submission

  • Standard macro production and validation for clinical development projects

  • Automatedprocess for submission ready packages includes Define XML, Reviewers Guide andAnalysis XPT data generation

  • CDISC standards for ISS/ISE reporting and FDA submission

MEDICAL WRITING

Weprovidemedical writing services to support clinical development program.

Our writers provide investigator brochures, clinical study synopsis, protocols, informed consent forms, clinical study reports for phase I to IV clinical trials.Our medical writerssupport abstracts, posters, presentations and manuscripts, clinical overview and clinical summary as per regulatory requirements.