Services
Our services include Site Monitoring, Site Management, Project Management, Clinical Data Management, Medical Writing, Safety Reporting and Statistical Support. We also provide staffing services to include Clinical Trial Assistants and site based Study Coordinators.
Monitoring
Our monitors provide complete services including; source document verification, regulatory review, drug accountability and comprehensive visit reports.
The majority of our Clinical Research Associates have over 10 years of monitoring experience. We have team members located throughout the US and Canada to allow for regionalized travel. The monitoring staff has experience with electronic clinial trial data capture and trials in phases I-IV.
Site Management
The monitors provide full site management based on the
requests of
the sponsor. It is common for our CRAs to assist with
recruitment, retention, protocol questions, provide site training,
query resolution, budget questions and SAE reporting.
Project Management
Our Project Managers or Lead CRAs will assist the in house
clinical
team as requested. Some examples include; CRA management
including trip report review, expense report review, tracking visit
schedules, CRFs monitored vs unmonitored, co-monitoring and audit
visits. They will also provide enrollment, patient visit
tracking
and assist with recruitment and retention initiatives as requested by
the sponsor.
Data Management
CUREM provides complete clinical data management services in
accordance with
FDA, ICH and GCP regulations. With experience in both paper and
electronic clinical trial data capture systems our data managers are
dedicated to
meeting, or exceeding database lock timelines. Services include:
- CRF and database design
- Database testing and validation of edit checks
- Coding of adverse events in MedDRA
- Coding of concomitant medications in WHODRUG
- CRF completion guidelines
- Verification of data including scientific review
- Query Management including resolution and tracking
- Database Lock including generation of final, validated reports, tables and listings
Medical Writing
CUREM can fulfill all of your medical writing needs including
completion of protocols, investigator brochures, INDs, regulatory
submissions, and research reports. Our lead medical writer has over 20
years experience in the pharmaceutical and biotechnology industries.
Pharmacovigilance
The safety department is capable of assuming all SAE reporting for a trial including first notification of SAEs, review of the SAE report and querying the site to obtain a complete report and medical records, writing of the clinical narrative, all regulatory submissions, SAE tracking and reconciliation with the clinical database.
Data Entry
If sites are enrolling rapidly and are unable to maintain data
entry
into the EDC systems our data entry specialist will visit the site and
enter data from the completed source documents. She will also
assist the site and sponsor with query resolution.
Stastical
Support
Our statistician has over 20 years experience working for a large pharmaceutical company. He is willing to provide support with study design, sample size calculation, protocol development, statistical analysis plans, interim analyses, DSMB reports and final analyses.
To find out how our company can help you achieve your goals email us at info@curemresearch.com.