CLINICAL TRIAL MANAGEMENT

We currently offer comprehensive management services for Phase I and II Clinical Trials.

We support our clients with expertise, commitment, and an unwavering dedication to the management of the clinical trials.

We work in close collaboration with you to define, collect, manage, and analyze quality clinical data to achieve the objectives of your clinical and product development aspirations. From the initial study planning and protocol development to peer reviewed publication and public information dissemination of the study outcomes, we partner with you to secure outstanding results and regulatory compliance at every stage of the clinical trials.

We provide a spectrum of management services including:

  • assitance with protocol development to identify and collect key data points required in the study.

  • protocol documentation review to enable compliance with IRB and ethical research requirements of the institutions involved in the clinical trial.

  • monitoring patient enrollment, consent, continuous study participation and patient safety.

  • specimen tracking, laboratory management, and monitoring assay completion.

  • data query, cleaning, integration and data conflict resolution.

  • interfacing with multiple stake holders (biobanks, research centers, clinical sites, etc.) to address any inconsistencies, delays and other challenges that can impact the clinical trials outcomes.

  • scientific support and review of publication materials, websites management and public presentation of the clinical trial outcomes.

We are your partner in health, dedicated to your success and working with you towards the best clinical trial outcomes.

AlephAstra LLC

info@alephastra.com

clinical.trials@alephastra.com