ProtonTree Inc. ®. is driven by the approach of collaborating with Customers to achieve high Productivity coupled with excellence and promptness. We at ProtonTree Inc � will accommodate all facets of solutions based on customer requirements encompassing a gamut of following services:

  • IT Staffing Assistance

    Project Management

    At ProtonTree we strongly believe that proactive identification of potential issues and timely resolution of all issues is essential for a quality drug development project to be completed on time. Our experienced PMI Certified Project Managers are fully prepared to lead our client's projects while providing regular updates.

    Our key services offered through Project Management are:

  • Strategy and planning prior to project launch
  • Timely project status and metrics reports
  • Coordinating swift response to changes resulting from protocol amendments
  • Open and timely communications on issues and their resolution
  • Work in harmony with all the other teams in ensuring the successful conduct of the study

  • Our clients can expect our Project Mangers to build a sound partnership with them by working towards the common goal of completing the project successfully on time. While our Project Managers at ProtonTree will plan adequately, we will have an open and honest ongoing communication with our clients as the realities of the project unfold. With our agility, commitment and experience, we are determined to seeing our clients succeed.

    Back To Top

    Data Management

    Capturing, cleaning and delivery of accurate study data is paramount in making key study decisions. Our Data Management teams collaborate with each of the study teams right from the proposal stage through database lock. We ensure that data management deliverables meet required upon standards by following stringent SOPs and Quality Assurance procedures. ProtonTree provides the following Data Management solutions:

  • Case Report Form (CRF) design
  • Database design and build
  • Data entry process
  • Data Management documentation
  • Electronic data transfers from external vendors
  • Query resolution and remote site management
  • Electronic data capture

  • Our experienced Data Management teams are fully engaged towards ensuring successful deliverables. We treat the role of progressing data from clinical monitoring through database lock as a core component of the study.

    Back To Top

    Bio-statistics and SAS®

    ProtonTree, Inc. bio-statisticians and analysts/programmers have extensive experience in the clinical research industry. All of our team members have at least a graduate degree and/or five plus years of experience working with pharmaceutical firms. The combined breadth of knowledge allows us to provide a full range of services to firms involved in conducting all phases of a clinical trial. We believe the inclusion of bio-statisticians and analysts/programmers in early stages of a clinical trial are imperative to the success of a trial being completed efficiently and on time.

    Our Bio-statistics and SAS® offerings are:

  • Study design, sample size calculation and Protocol development
  • Assisting with creation of Case Report Forms (CRFs)
  • Creation of bio-statistical analysis plans
  • Bio-statisticals analysis and SAS programming/analytical expertise
  • Creation of analysis datasets
  • Validation of data sets to ensure accuracy and completeness
  • Creation of integrated clinical reports (safety, efficacy and new drug application)
  • Provide electronic submission of protocol and study results to FDA
  • Assist in writing of final clinical study reports

  • Delivering accurate reports on time, with professionalism and integrity, is our focus. Understanding and addressing our client's needs are our goals.

    Back To Top

    Quality Assurance

    The ProtonTree Quality Assurance team ensures compliance with standards of good clinical practice and good laboratory practice.

    Good Clinical Practice (GCP) Audits

    Our experienced auditors follow FDA and ICH regulations and guidelines to ensure consistent audits across global trials. Our auditors work closely with each client to develop and implement audit plans that utilize and comply with the client's Standard Operating Procedures (SOP).

  • Assisting with creation of SOPs and WIs
  • Preparation of essential document review guidelines
  • Investigator site audits to verify the accuracy of the data being submitted to the sponsor and to ensure the site is complying with the protocol, regulations and guidelines
  • Protocol and Informed Consent Form reviews for compliance to GCP and SOPs
  • Database audits
  • Final report audits
  • Sponsor/monitor/CRO audits
  • Institutional Review Board/Independent Ethics Committee audits
  • Review of key deliverables (protocols, reports, datasets, etc.)
  • Compliance and auditing services include vendor and site audits
  • Preparation of investigators for regulatory authority audit

  • Good Laboratory Practice (GLP) Audits

  • Protocol reviews
  • FDA-mandated audits of in-life study procedures
  • FDA-mandated final report audits
  • Facility audits
  • Back To Top

    Training & Product Development

    Back To Top

    Maintenance of outsourcing IT staffing requirements

    Back To Top

    Program Management

    Back To Top

    © Copyright Protontree, Inc. 2005 - 2013, All rights reserved.