FIRMPLACE

Safety and Study Management

Medical writing

Firmplace provides medical writing that is clear, comprehensive, carefully focused and precise.  The documents are ICH GCP compliant and can be quickly and easily read and understood by scientific, medical and regulatory professionals.

Clinical writing can be offered on the stand-alone basis as well as with full services provided by the company.

        - Protocol design and writing;
        - Clinical study report writing;
        - Integrated summaries of safety /efficacy results;
        - Investigator's brochures;
        - Efficacy attestation document writing;
        - Claims support document writing;
        - Study concept sheet writing (summary of protocol);
        - Scientific publications (journal articles, abstracts, posters).

Clinical safety management

 

For any clinical trial safety of study subjects is the priority. Our professional team will provide medical oversight of the studies being involved in all of its stages. We will provide medical support and monitoring for all processes with highest quality and ethics standards. Analysis and evaluation of all safety issues will be done followed with necessary reports.

With our services you will always keep track of all safety issues and will not miss any important one:

 

        - Provide medical oversight of planned and ongoing studies;
        - Safety review of Study Protocol, Informed Consent and other key documents;
        - Eligibility assessment of study subjects;
        - Adverse event assessments and reporting;
        - Detection of potential safety signals during studies and further processing;
        - Reconciliation of adverse events and "End of study" safety report writing.

Study management solutions

We are providing simple e-solutions in order to ensure tracking of all internal processes and evaluation of projects. With massive number of trials and consequently issues raised during each of them it is very hard to keep track of all those issues. Simple tracking system is a very powerful and handy tool in this case.

Evaluation of the projects is an important step in development. Selection and promotion of effective projects is essential for overall company success. On the other hand timely detection of the projects which are draining resources and giving no output will enhance company's efficiency and profitability.

 

        - Develop internal study tracking tool system;

        - Develop and publish project/franchise dashboards.

 


 

Why Firmplace

Exceptional outcomes

Experience - 10 years of continues delivery center experience in clinical and laboratory operations.

Quality of work - Ongoing support of large pharma-clients speaks of extremely high ethics in work attendance and delivery of the exceptional results.

Sustainable costing - We are proud that over the past 10 years we have offered our clients the most competitive and predictable costing in the CRO sector.

Responsible and accountable partner with supreme communicaitons.

  Please Contact Us to discuss your interest further.