Phase Experience

InFocus Clinical Project Managers, Clinical Research Monitors and administration have worked for and with sponsor companies and CROs large and small, offering a unique and invaluable experience and insight.

 

Phase 1 Experience


InFocus Clinical Research has a proven and committed group of phase I sites pre-qualified to execute on your Phase I needs. Additionally, InFocus Clinical Research specializes in providing clinical study expertise for the management of your Phase 1 trials. Regardless of your Phase I study type: first time in human, a dose tolerance study, a food effect study, a Pharmacokinetic (PK) study or a Pharmacodynamic (PD) study, our experienced staff can work with you to ensure:

  • The Phase 1 center and personnel are trained on conducting the trial.
  • The appropriate regulatory documentation is collected and maintained.
  • Clinical data are being collected using Good Clinical Practices.
  • Adherence to study protocol.
  • Safety data are being collected and reported to regulatory agencies

Through our extensive Phase I experience, we have found that PK trials demand an additional level of expertise because of their uniqueness and complexity. In addition to the standard activities performed on other phase I studies such as verifying informed consent, protocol compliance, AE reporting, and investigational product handling, PK studies also require:


InFocus Clinical Research will provide monitoring services to ensure your Phase I study is being conducted according to the protocol and local regulations. To facilitate these services in a timely and cost-effective manner, our monitoring staff is located throughout the country near most Phase I facilities. This regionalized model, combined with our experience with and knowledge of the core ophthalmology phase I centers enables InFocus Clinical Research to quickly respond and provide results to our client needs.

InFocus Clinical Research always customizes solutions to our partners study specifications in to increase efficiency and productivity. The InFocus Clinical Research study team is directed by the InFocus Clinical Research project manager who becomes an extension of your internal team in order to make the communications link direct, concise, and effective.

Phase 2 & 3 Experience


Phase II and III studies require a different level of expertise due to the length, complexity in design, and knowledge of the diverse indications. InFocus Clinical Research is able to provide you with the confidence and reassurance that our wide range of clinical trial experience and services are able to conquer the myriad issues faced in research today. Our experienced, therapeutically aligned staff ensure:

  • Site and investigator selection are done with the best interest of the trial in mind.
  • The investigator and site personnel are properly trained on conducting the trial.
  • The appropriate regulatory documentation is collected and maintained.
  • Clinical data are being collected using Good Clinical Practices.
  • Adherence to study protocol and GCP
  • Safety data are being collected and reported to regulatory agencies
  • Data is collected, queried, and reported in an efficient manner.

To facilitate services in a timely and cost-effective manner, our staff is located throughout the country near most major medical facilities. Being therapeutically focused, our staff have worked with most of your important investigational sites for years on dozens of proocols. As an added benefit to saving our clients money through native efficiency, this rapport and respect with your sites ensures greater commitment to your study, faster recruitment and better responsiveness.

InFocus Clinical Research always customizes solutions to our partners study specifications in to increase efficiency and productivity. We provide our clients direct access to senior staff throughout the life of their project to ensure that any questions or issues related to the trial are addressed quickly.

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