Data management and statistics

We offer power analysis, development of paper CRFs and Statistical Analysis Plan. Development of e-CRFs, data management and statistical analysis are performed by our long-term partner - ICTA PM, Dijon, France, by means of ICTA PM’s original IT platform.

Learn more about our experience

IT collaborative web based platform, customized to the study needs, is an integrated suite of server capabilities that improves efficiency of trial management by accelerating shared business processes, giving a screened secure access to study-related documents (ITMF, Case Report Forms, Data Query Forms, laboratory resulst) to authorized stakeholders, and facilitating in real time information-sharing (schedules, study mail box…) between all partners. The portal allows a secured access to all different IT tools related to the projects (ITMS, e-CRF, IxRS, IReport).

The ICTA Trial Management System (ITMS) allows management of the investigative sites, clinical activities, documents, schedule of the monitoring visits including the monitoring visit reports, the study material, the investigators fees, the study drug management, sharing of information on milestones (study, countries, sites) etc. The system can be customized according to both the projects and the stakeholders in the study. It is accessible to all partners under validated secured key, facilitating international management.

Its architecture supports regulatory compliance, complex data management and quality control. The system is fully 21 CFR part 11 compliant. ITMS also brings a powerful multi-site collaboration capability for clinical trials and allows generating automatic alerts and workflows. It also has a special reporting section that enables to have instant study overview on strategic and operational level at your fingertips

Single entry, standard or interactive double entry, electronic entry are options to be decided by the clients. We adapt to these different kinds of service thanks to infrastructures and an array of peripheral, logistic and IT processes meeting FDA requirements. Complete and validated bases are ensured through meticulous management of correction requests and the use of appropriate quality processes.

The entire Biometrics Department is thus covered by an ongoing training process focused on heuristic methodologies or special points requiring development.

We use the following statistical methods: Variance and covariance analyses, Linear and logistic regressions, Survival analyses, Sensitivity/specificity analyses (ROC curves), Multifactorial analyses, (PCA, FCA, discriminatory analyses), Proximity analyses, Neuronal networks, Bayesian networks.

Bayesian statistics

Is an approach for learning from evidence as it accumulates. Its use in clinical research is spreading because it allows considering data from smaller trials as part of a continual data stream. This approach can also accommodate historical data on the compound. All relevant sources and accumulating results can be evaluated at any time and used for modifying the design of the trial, for example, by slowing or stopping recruitment, altering randomization to favour more effective therapies, changing the number of treatment arms, and changing the structure of trial population to focus on patients of special interest. This approach may accelerate the product development as well as result in saving its costs.

MedDRA coding

Pharmnet may assist you also with only some particular activities like in the MedDRA coding in both Czech and English languages. We have been doing MedDRA coding for several years, so we may offer experienced staff (physicians) to assist your research team.

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