Qtech
personnel have extensive experience in database design and
development, data consolidation and statistical analysis.
Beginning with the proposal process we are dedicated to provide
exceptional solutions to the pharmaceutical, biotechnology
and medical device community. One of the company founder is
appointed as project team leader and provides a major point
of contact throughout the project.
Committed
to high quality data, Qtech utilizes experienced project teams,
and efficient, real world-tested processes to avoid inefficiencies
and streamline the data management process. A dedicated team
work is renderd to work with you from the project's outset
- and throughout - to follow these processes and gain your
sign-off at critical points of the project. They remain focused
on maintaining your quality standards. Whatever your data
needs might be, our project team adds experience, innovation
and commitment to create, coordinate and deliver results that
keep you moving forward.
Our
secure Web portal allows you to review scanned images of case
report forms (PDF format), summary study management reports,
SAS datasets and study documentation. Our entire data management
and biostatistical approach centers are on adherence to the
FDA's 21 CFR Part 11 guidelines. Our network environment has
been qualified and our clinical data management system has
been tested and validated.
Our
database design and development strategy focuses on full disclosure
of the database fields, their attributes and all data validity
checks. Our summary study management reports provide you with
critical details regarding the CRF page processing status
by site and subject, query status, data clarification form.
Clean subject reports provide insight into the progress. We
resolve outstanding issues for any study subject prior to
database freeze. Reports demonstrating our consistency in
medical coding and identification of outstanding and/or missing
CRFs are also provided. You can 'look over our shoulder' and
monitor our progress from anywhere. Data is usually provided
as SAS datasets but can also be exported in other formats
to meet your specific needs. |
| Project
Management - where everything
comes together |
You
can rely on Qtech experienced employees for comprehensive
project management services. Our professionals have worked
in Phases I-IV, and have the expertise to manage these projects
as well as develop protocols and case report forms for upcoming
trials. We can use our own project management tools that have
been tested and refined over years of use in clinical projects
or custom-design tools for your project. The tools we use
are designed to maximize project efficiency and the effectiveness
of the project team.
You can use our consultants
to leverage the efforts of your in-house project team or rely
on us for a complete outsourced management solution. Either
way, our professionals manage projects with the utmost attention
to detail from beginning to end
|
| Clinical
Monitoring - keeping trials
on track |
Qtech
offers flexible clinical monitoring services, designed to
accommodate any type or phase of a clinical trial. We can
deliver experienced professionals—individuals or entire
teams—to monitor all aspects of a clinical trial or
simply to fill critical knowledge or experience gaps in your
team. If you need a complete monitoring team, we can provide
one with the right background and experience for your specific
needs.
Our experienced clinical research
professionals can easily integrate with your in-house clinical
team to manage local trials, or you can take advantage of
the Qtech national network of clinical research professionals
for trials requiring regional monitoring. Whether your clinical
trials are conducted locally, regionally, nationally, or worldwide,
we can provide you with the proven professionals you need.
|
| Site
Management - Ensuring
Quality |
Choosing
investigators and study centers can be a resource-intensive
task. Qtech clients can use our investigator database or outsource
the identification, evaluation, and selection process to us.
We can quickly and easily help you find the best investigators
and study centers for upcoming trials. When necessary, we
can train site personnel and provide tools to maximize a site's
effectiveness. Good training, proven tools, and a solid relationship
with CRAs result in fine data, higher subject enrollment,
and fewer errors. |
| Quality
Assurance - Every step of
the way |
| Qtech offers a wide
range of quality assurance auditing services. For example, we
can provide an independent audit of clinical projects in progress.
We can conduct quality assurance audits and reports on our own
monitors. We can also visit study sites or your own internal
departments to conduct quality assurance audits. Qtech helps
you assure the highest quality sites, staff, and results for
your projects. |
| SOP
Development - saving time
and Streamlining operations |
| Clinical Standard
Operating Procedures (SOPs) play a critical role in conducting
successful trials. Qtech can provide a complete package of new
clinical department SOPs and Guidelines, or we can audit and
edit existing SOPs to ensure maximum clinical effectiveness.
Qtech offers tremendous flexibility
for clients You can purchase a complete package of clinical
department SOPs, or you can purchase individual SOPs, such
as monitoring SOPs, as needed. We can also provide you with
customized templates, monitoring SOPs with attached forms
and templates, and staff training on SOPs. With extensive
experience in procedures and clinical operations, our consultants
can save you time and significantly improve project processes. |
| Thearuptic
Area |
- Analgesia.
- Cardiovascular.
- CNS.
- Dermatology.
- Endocrinology.
- Gastroenterology.
- Genitourinary System / STDs.
- Hematology.
- Infectious Disease.
- Immunology.
- Oncology.
- Ophthalmology.
- Pediatric.
- Pulmonary / Respiratory.
- Rheumatology / Musculoskeletal.
- Transplant.
- Vaccines.
|
| Medical
Writing |
• Clinical Protocols
• Investigator's Brochures
• Clinical Sections of Annual Reports
• Clinical Study Report
• Safety/Efficacy Summaries
|
| Data
Management and Data Analysis Service |
- Data management
•
Understands the protocol content.
• Data Management Plans.
• Relational Databases.
• Clinical Database Design.
• CRF Tracking.
• CRF Data Entry.
• CRF Data Validation (e.g. data review, cleaning,
query generation and applying data handling conventions).
• Safety Review.
• SAE Reconciliation.
• Archiving Database and Associated Information.
• Database Updates.
• Database Quality Control Audits.
- Data Analysis
• Applying test (eg. anova, reg,
mcnemars etc).
• Statistical report writing.
|
| Biostatistical
Services |
• PK Analysis.
• Sample Size Calculations.
• Study Design Assistance.
• Statistical Analysis Plan.
• Statistical Analysis Programming.
• Final Analysis Report.
• Data Safety Monitoring Board (DSMB) participation.
|
| Investigator
support |
| Investigators are
key to success on your clinical trials. At Qtech we ensure your
investigator teams get the service and support that sites deserve
whilst they keep your trial on track. Qtech routinely provides
the following services for your investigators; |
- Attendance at Investigator and Study
Set Up Meetings.
- On-site training.
- Customised, easy-to-use investigator
manuals.
- Translations of key documents in any
language.
- Local courier contacts visit the sites.
- Flexible courier cut-off times assist
with patient recruitment .
- Weekend pick-up of samples on request.
- Assistance with shipping and packing
samples .
- Automatic kit supply.
- Study specific or bulk supply services.
- Dedicated site support from Qtech project
co-ordinators and project managers
- Supply of centrifuges, freezers and storage
containers worldwide.
- AX and surface mail reports.
- PDF & Remote Data Access.
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