COVID SOLUTIONS

Business Continuity amidst a Pandemic and/or Pandemic Resurgence – COVID-19

NCGS has further developed, expanded or instituted evolved services to meet the needs of active trials and our subjects to protect data integrity and patient safety as follows:

  • COVID Crisis Management Team
    • Members from each ongoing trial and executive management
    • Weekly meetings and evolving program guidance as government mandates, site mandates, etc. evolve; communicate immediately to team; measure compliance in an ongoing fashion
    • Shared intelligence across the enterprise, merging perspectives and resulting in best approach for each trial specific circumstances
  • Access Determination, duration of access limitation
    • Site study staff and ancillary staff required for radiology, lab, etc.
    • Subject
    • CRO/CRA
  • Expanded centralized monitoring services (E-CMS)
  • Source Access
    • Employing remote electronic medical record (EMR)access through a secure VPN
      • Determine to what extent CRA has access
      • Determine extent of data in EMR versus what portion is stored elsewhere (paper, etc.)
    • Redaction and uploads of source in a CFR Part 11 compliant platform that allows for secure electronic redaction by the site before submitting to the platform adding another layer of privacy protection. (Example: IBM eClinical, a tool available for free within their platform or as a standalone technology at a low price)
    • Manual redaction and upload to secure VEEVA site portal
      • Note: IBM has made this free to the site and site provides access to the CRO for review)
    • Telemedicine assessments and completion of MD required assessment tools
    • Lab, radiography or other department assessments
      • Can these be done locally?
      • Impact on trial
      • DM updates on lab normal ranges
      • Regulatory collection of lab/radiography licenses; lab normal ranges
    • Patient Diaries
      • eDiary- internet concerns for uploads or on-line cloud access; will temporary internet fobs be required if subjects “sheltering in place” with no café or local library internet back-up access. Impact on compliance thresholds without data integrity issues
      • Paper- determine method of submission between visit if required
    • Home health visits and data submission policies
      • MSA in place with two global providers
      • Determination which assessments can be done
      • Determine method of reporting to site and responsible person for EDC updates
    • Virtual PSSVs and SIVs using video teleconferencing (Web-X) and video tours of the facility for inspection and documentation of both
    • IRB notification of processes where required (which is almost all sites)
    • ICH-E6(R2) compliance- GAP and RISK analysis when virtual or home health visits are employed
    • Compliance with ongoing and evolving guidance from relevant competent authority relevant to the pandemic
    • Drug –
      • Define methods of getting IP to the subject or delivering drug to the subject remotely. (Compound driven largely).
      • Drug shipments to the subject directly are in violation of state and federal law.
    • IRB directive example
      • Review the study to determine if any study procedures that require participants to come to a hospital or a clinic can be eliminated or managed remotely through telemedicine or home visits.
      • This would require an IRB determination stating that changes in these procedures to either eliminate them or manage them remotely would not impact the integrity of the research. The wording below may be changed to accommodate changes in the current public health outbreak landscape but should be comparable to the following:
        • Have you traveled to China, Iran, Italy, Japan, or South Korea in the past 14 days?
        • Have you had any of the following symptoms in the past 14 days without confirmation as something other than COVID-19 (such as a positive flu test, chronic medical condition, etc.)?
          • Fever greater than 100.4 degrees Fahrenheit
          • Cough
          • Difficulty breathing
          • Sore throat
        • In the last 14 days, have you lived with, visited, cared for, or been in a room for a prolonged period of time with someone who is under investigation or has been confirmed for COVID-19?”
        • If a participant says yes to any of the above questions direct your study staff regarding future screening after the incubation period per the CDC (14D) and / or symptoms resolution window suggested by the CDC.
      • IMVs
        • Assess each site for access and determine method of visit as access allows
        • Screening subject for coronavirus- generally does not require IRB notification or approval as this follows site or state directive
        • Sites open to staff and /or subject, but no CRAs
          • Virtual visit
          • Confirmation letter as usual denoting method planned, times needed with each department, main coordinating staff member on site
          • SKYPE/Web-Ex, FaceTime for each staff as required, inclusive of PI
          • Document IMV as usual noting the remote nature
          • Resolve outstanding data and/or subject management issues
          • FU Letter documenting oversight, finding, issues, actions, etc.
          • Update visit log to indicate remote visit at next onsite visit
          • Drug reconciliation using drug log and photo of return drug with lot # visible
        • Evolving circumstances
          • Constant communication to determine how circumstances have changed at a given site, state, etc. and adjust operationally to meet the safety and data integrity goal.

PHASE 1 CAPABILITY

For all of our Phase 1 studies, NCGS provides a full range of clinical services, including in-house biostatisticians for pharmacokinetic and pharmacodynamics analyses, medical writing, data management, and a full range of regulatory services.  Phase 1 studies require an intimate and collaborative partnership between Sponsor and CRO if data lock is to be achieved both efficiently and with the highest quality data.  Success in pivotal studies begins with attention to detail in phase 1, and our tenured CRAs provide the attention our Sponsors demand.  With dose escalation studies, constant communication between sites, CRO, and Sponsor is critical to avoid losing precious time and money.  NCGS’ approach provides our Sponsors with structured and proven processes that produce quality phase 1 data on time and within budget, every time.

As adaptive trial design moves mainstream, this collaborative approach will become more critical to efficiency and success in the clinic.  The foundation for NCGS’ focus on long-term relationships with both Sponsors and sites is often built during phase 1 trials.  Due to the collaborative nature of phase 1 trials, Sponsors quickly learn to appreciate NCGS’ way of doing business.  NCGS maintains relationships with many experienced phase 1 centers, and these relationships are the catalyst for lower costs, speedy trial results, and greater collaboration.

NCGS places a high priority on conducting phase 1 trials to establish lasting relationships with Sponsors.  Our intense focus on collaboration and seasoned processes brings problems to the forefront in time to solve them before they have a negative effect on the overall trial results.  Considering NCGS trial managers and lead CRAs often shepherd a compound throughout the development process, we offer only highly tenured leaders that quickly put Sponsors concerns at ease and make NCGS instantly feel like an extension of your own operational team.  After all, every success boils down to what motivates the players involved; NCGS makes sure every person involved is focused on the same end goal and has the tools and training they need to reach that goal.

PHASE 2-3 CAPABILITY

Phase 2 and 3 studies require robust capability and experience to efficiently and consistently manage the large number of sites and subjects needed to produce the quality data necessary for agency approval.  NCGS’ 30+ years of trial management experience includes a broad spectrum of indications and therapeutic areas.  Our lead CRAs and Project Managers are all very experienced leaders and often are able to spot issues before they become problems.  NCGS CRAs are not assigned to trials based on their locale, rather they are assigned based on trial experience.  No CRA is assigned more than 2 studies at one time, and every trial employs back-up PMs and CRAs in the event vacations, illness, or other unforeseen circumstances arise that could delay critical timelines.  NCGS’ 30+ years of experience in business provides us the ability to offer a full range of clinical trial services for our Sponsors:

  • Clinical Operations and Clinical Monitoring
  • Clinical Call Center– Screening, Recruitment and Safety
  • Data Management, EDC
  • IWRS Fully integrated to EDC Platform (eliminating duplicate license fees)
  • eTMF and CTMS Management
  • Medical Monitoring and Safety Management
  • Grants, Contacts, Site and Vendor Payment
  • Regulatory Compliance and Quality Assurance
  • Global Strategic Sourcing
  • Medical Writing
  • Biostatistics
  • Pharmacovigilance
  • Ex-US Regulatory Affairs
  • Trial Rescue

What separates NCGS from the rest?  

  • 30+ years of clinical trial experience
  • 78 approved products
  • Zero FDA 483s
  • CRA Average Experience  – greater than 10 years
  • Functionally flexible teams
  • Ever present executive oversight
  • In depth knowledge resulting in a higher level of attention to detail
    • Contingency Plans and Process Improvement
  • NCGS moves beyond planning contingencies; plans are implemented from study start
    • For each staff member there is a back-up staff member and for each effort there is a contingency to ensure success
  • Continuous process improvement in each functional area
  • Turnover Rate- <3%
  • Diversity Supplier- NCGS, Inc. is a certified “Diversity Supplier” by WBENC (Women Business Enterprise National Council).  
  • Clinical Expertise- Complicated therapeutic areas of CNS (neuro-psych, movement disorders, pain control), infectious disease, cardiology, critical care, oncology-hematology

NCGS places a tremendous amount of emphasis and respect on unification of NCGS, the Sponsor and the site as one team.  Our specific management model provides consistency between the three entities with shared collective intelligence and a unified team approach. Unanimity in processes enhances quality outcomes and fosters innovation focused on constant improvement. The result, ensuring successfully conducted trials with intact evolving relationships for future development endeavors.  NCGS’ elite tenured project teams are adept at developing and securing long-term quality relationships with sites and Sponsors.

PHASE 4/POST MARKETING

RESCUE SERVICES

Issues and problems in clinical trials are inevitable given how many critical moving parts are involved in getting a study to the finish line.  So much so that it seems Murphy’s Law is intricately laced into every study protocol ever written!  Often times, it is a lack of focus on quality and unseasoned processes that steer trials off course to the point that an unreasonable amount of time and money are being wasted.  NCGS’ processes have been tested and improved consistently for more than 30 years, and this focus on quality can be a huge asset to any clinical trial in disarray.  It is because of our focus on quality that NCGS now has a great reputation for successfully rescuing studies from our much larger global competitors.

Tired of excuses from your CRO?  Call NCGS.

eTMF

NCGS will establish and maintain your trial master file in audit ready compliance with our robust and expanding TMF/eTMF centralized team of more than 100 experienced regulatory document specialists and regulatory associates. NCGS’ e-TMF preferred solution meets global regulatory compliance requirements (GCP, ICH E6, FDA, 21 CFR Part11 / EU Annex 11 compliant, EMEA, etc.) and follows the hierarchy and indexing standards from DIA’s most current version of the TMF Reference Model which is an extension of the EDM Reference Model addressing standards for electronic submissions. NCGS has proven talent regarding audit readiness as evidenced during our most recent FDA audit 27FEB-1MAR 2012 for an international infectious disease trial resulting in zero findings.

DIAGNOSTIC/DEVICE