Become a Future Investigator
Collaboration with Frontier Clinical Research can provide potential Principal Investigators with:
- Development of your clinical research capabilities to supplement your Medical Practice with additional income without incurring costs of certified clinical research staff.
- Frontier business development provides investigators with recruitment and contracting services with Pharmaceutical and Device Companies.
- Highly trained, skilled, and certified Clinical Research Coordinator(s) to your emerging clinical research site.
- Study accounting records including accounts receivable and accounts payable.
- Submission to the required Institutional Review Board or Independent Ethics Committee (IRB/IEC) for approval and provide expertise for ongoing regulatory processes.
- Disease specific counseling and instruction on study medication dosing for each individual patient.
- A multitude of techniques to assist with patient recruitment including the use of local and centralized vendors to maximize enrollment.
- Patient follow-up during and immediately after the clinical trial.
- Developing Informed consent form (ICF) translation into vernacular languages and assist with the documentation of the informed consent process as required by ICH/GCP/CFR standards and regulations.
- Completion of all site initiation procedures and trial close-out operations.
- A proper pharmacy with secured, temperature controlled, and documented storage of investigations medications and background therapies.
- Archival of trial-related documents and appropriate maintenance for the timeframes specified by the Sponsor.
- Reporting adverse events, serious adverse events, adverse drug reactions, or device failures to the Sponsor or CRO and the IRB/IEC.
- Ensuring strict protocol compliance and deviation reporting.
- Advising & alerting investigators of potential protocol violations.
- Advising & alerting investigators of potential ICH-GCP violations.
The site is usually a hospital or a similar health care institution that has adequate infrastructure to meet the requirements of the clinical trial protocol.
• We bridge the gap between Pharmaceutical companies and patients by recruiting patients into clinical trials, allowing for more affordable and new cutting-edge medications to be approved in the market faster.
• We have an enviable record of having provided services to many of the top pharmaceutical and biotechnology companies, both large and small.
• Our clinical team has nearly 25 years of combined clinical research experience.
• Of the remaining 20%, Twelve percent (12%) will leave the field after their first two years of clinical research
• Thus 92% of principal investigators will FAIL to adopt a successful clinical research program at their facility
Aligning your sites enrollment with the top 30% of clinical research sites cannot be understated. It is the single most important factor in determining the success of your clinical research program.
• 11% of sites selected are never activated due to their inability to enroll subjects
• Poor site selection can increase costs by 20% causing delay of study
• 80% of clinical trials fail to meet enrollment deadlines
• 54% of new investigators are never used again due to poor enrollment or poor data quality
• Lack of experience, training, and orientation to the field
• Inability to find staff or increase staffing to meet clinical trial program needs
• Internal candidate is too busy or lacks commitment
• Lack of experience, interest, time and availability
3. Lack of study opportunities
• Actively pursue new federally funded or privately supported clinical trials from feasibility to site selection.
• Work with sponsor to conduct the feasibility process to assist the site to secure their selection for clinical trials.
• We negotiate and execute clinical trial contracts.
•Site initiation and trial close-out operations.
• Provide sites with CRC staff knowledgeable of and qualified to conduct every aspect of clinical trials while maintaining a high level of patient care.
• We arrange for necessary office and medical equipment and supplies for set up of the research site as well as maintain yearly calibrations.
• We provide study oversight management of the conduct of clinical trials at your site to reduce potential ICH-GCP violations.
• Help maintain current trial related certifications and trainings for PI’s, Sub-I’s and all study staff.
• Assist sites with FDA or Sponsor Audits.
• Store and maintain trial related records and retention samples as required by Federal Regulations (21 CFR 312.62) or Sponsor requirements. (Usually 15 years unless otherwise specified)
• Provide trial specific advertising for the site to assist with recruitment. While instilling a high focus on patient retention (Retention is Key).
• Astra Zeneca: Tudorza – treatment of COPD
• Biocryst: Peramivir – treatment of influenza
• Novo: Tresiba - treatment of diabetes
• Shionogi: Xofluza - treatment of influenza
• Sanofi: Soliqua - treatment of Type 2 diabetes
• Synergy: Trulance – treatment of idiopathic constipation or IBS-c
► Meticulous management of necessary records of study related activity which includes case report forms, drug dispensation records, maintenance of required legal research documentation within the regulatory binders, etc.
► Enroll subjects in the study as per the study protocol guidelines in order to meet the site's stated enrollment goals.
A Clinical Research Coordinator is responsible for conducting trials as per the GCP guidelines under the supervision of the Principal Investigator (PI). Although the PI has the overall responsibility for performing the trial, it has been stated that the CRC is the heart and soul of the clinical trial and that, eventually, it is the CRC who carries ahead the research objectives, in that way playing an important role in the success of the clinical trial.
► Prepare for, be involved in, address the questions and queries of an FDA auditor during an inspection whether announced or unannounced.
► Record Adverse Events and Serious Adverse Event information, consult with investigators concerning causality and submit to the Sponsor, and IRB within the required 24 hour reporting timeframe requirement of the FDA.
► Create and Prepare any trial related paperwork such as source documentation, protocol worksheets, adverse event report forms, procedural manuals and progress reports.
► Create, Prepare and submit initial, quarterly, and yearly study reports to the Investigational Review Board.
► Manage subject registration to make sure that informed consent is effectively obtained and properly recorded.
• No financial constraints
• No disrupting your staff processes or training
• No administrative burden
• What questions do you have regarding Frontier Clinical Research?