The goal of Clinlogix is to work closely with our clients to define, refine, support and execute on projects with clarity and accountability. Based on the needs of our client, we will define the services and support required and establish achievable timelines with clear roles and responsibilities in place.

Study Start-up and Site ID Services

Study Start-Up

A critical key to a successful project is a rapid and efficient Study Start-up. Clinlogix has developed and implemented systemized processes and procedures that result in efficient, accelerated project start-up times.

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Site Identification

Choosing the right investigative site with access to a suitable patient population requires tremendous skill and experience. At Clinlogix, we have both. We create teams with proven expertise in implementing clinical trials and recruiting subjects, assuring that your site service requirements are fully addressed to your complete satisfaction.

Contract and Budget Management

Without the right skills and processes, the contracting process can cause significant delays during the study start-up process.

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Trial Management Services

Project Management

Clinical research is the fundamental basis of medical progress. It is a long path from the initial idea to the commercialization of a drug or a medical product. Following the completion of the pre-clinic stage, Clinlogix will accompany you with professional support from phase I onwards – from research to market launch, or to indication expansion if deemed necessary.

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Clinical Monitoring

When you delegate oversight of your investigative sites for regulatory compliance and patient safety, there is nothing as important as your reputation and success of your research project. Choosing the right experienced Monitoring Team to represent you is of utmost importance.

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Data Management

Clinical Data Management (CDM)
Clinlogix’s global team includes experienced CDM professionals located in key geographic regions of the world, including the US, Europe, and South America.

Clinical Data Management Service
Clinlogix has been involved in the evolution of Electronic Data Capture (EDC) and other clinical systems for years as an industry driver.

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Biostatistics – Programming

Clearly defining study objectives and validating study design is essential to project success.  The data sets, collection process and interpretation and reporting mechanisms need to be optimized to ensure the statistical accuracy of your trial, whether for traditional designs or emerging strategies.

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Safety Management

Clinlogix safety specialists provide efficient, flexible, and cost-effective services to the medical device, pharmaceutical, biotech, and consumer health organizations; The team manages safety both in the clinical development and the post-marketing space.

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Clinical Regulatory

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Clinical Regulatory Strategy

Choosing the appropriate regulatory pathway requires a strategy based on the analysis of the Clinical Strategy Assessment.

Case Study

Clinical Evaluation

Development of clinical study documents, study authorization submissions, statistical analysis, safety reporting and report writing.

Post Market Surveillance

Proactive planning to continuously gather safety and performance clinical data.

Vigilance & Reporting

Reactive implantation, validation, training and periodic reporting procedures.

Other Services

Medical Writing

The Clinlogix medical writing team is comprised of experienced professionals who produce concise, substantive, and polished clinical documents that provide clarity and are scientifically accurate from protocol to package insert. Most of our medical writers are members of the American Medical Writers Association or the European Medical Writers Association.

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Grant Management

Our Grants Manager Select program provides clinical trial Sponsors and Contract Research Organizations (CROs) with an online environment to efficiently negotiate budgets with investigative sites.

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Patient safety is of paramount concern during a clinical trial – especially when the number of adverse drug reactions may make it difficult to detect patterns of serious side effects – and after approval, when the effects of long-term exposure remain a concern.

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Project Rescue

Due to the complexity of clinical trials and the constant struggle to keep them on schedule, Clinlogix is often called upon to resolve issues when processes do not go as planned. Clinlogix’s resourcefulness and focus on quality has led to our reputation as a first-class provider of clinical trial rescue services.

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Quality and Compliance

Quality Requirement

Trust is good…In view of the ever increasing regulatory requirements, we are committed to excellence in quality.

Quality Assurance and Quality Control

… Control is better.In our company, the planning, conduct, and analysis of clinical trials are performed in accordance with current national and international laws and regulations.

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On-going training is integral to keep current on best practices and regulatory changes.

  • Regulatory Requirements
  • Study Site Training
  • Protocol Compliance
  • Safety
  • CRF Completion
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