Our SERVICES

Statistics

Statistical Services

With an average of over 16 years’ experience our team consists of a number of highly motivated and friendly statisticians. Our team offers a range of services with quality that is derived from decades of experience and industry associations.

  • All Phases of clinical trials and publications, including pre-clinical
  • A wide range of therapeutic areas including Oncology, Immuno-oncology, Neuroscience, Cardiovascular, Respiratory, Infectious Disease and Nephrology
  • Statistical methodologies including survival analyses, multiple imputations, simulations, mixed effects, Bayesian and multiple comparisons
  • Experience in trial design including parallel, crossover, adaptive, observational, non-inferiority, and group sequential
  • Variable client base from academia to multinational pharmaceuticals

Statistical Services

With an average of over 16 years’ experience our team consists of a number of highly motivated and friendly statisticians. Our team offers a range of services with quality that is derived from decades of experience and industry associations.

  • All Phases of clinical trials and publications, including pre-clinical
  • A wide range of therapeutic areas including Oncology, Immuno-oncology, Neuroscience, Cardiovascular, Respiratory, Infectious Disease and Nephrology
  • Statistical methodologies including survival analyses, multiple imputations, simulations, mixed effects, Bayesian and multiple comparisons
  • Experience in trial design including parallel, crossover, adaptive, observational, non-inferiority, and group sequential
  • Variable client base from academia to multinational pharmaceuticals

Case Study 1:

Plus-Project provided statistical consultancy support for a business priority regulatory submission to a large pharmaceutical company. Statistical consultancy tasks included production and validation of analyses required to respond to regulatory questions, statistical analysis and report writing to create meeting materials for a drug advisory committee. Statistical support was provided during the drug advisory committee meeting which included rapid response assistance. Additional tasks involved the production of publication materials and review of ADaM domains created using legacy data.

Case Study 2:

Plus-Project consultants have provided statistical review of study proposals and publications, statistical analyses and statistical advice to support publications. Literature review to assess a novel biomarker as a surrogate outcome, and review of clinical research organisation deliverables (protocols, statistical analysis plans and tables, figures and listings) have all been performed for a large pharmaceutical company.

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Our SERVICES

FSP
Flexible Resourcing
CDISC & CSR Reporting