Customized Clinical Research
Clinical Monitoring and Site Management
Clinical Trial Planning
- ClinPro Trials can assist you with
- Site identification & selection
- Site feasibility assessments
- Site qualification & initiation
- Budget and contract negotiations with sites
- 100%, Targeted or Risk Based monitoring
- Ongoing site monitoring & management
- Regulatory document collection, review & management
- Management/facilitation of IRB/EC submissions
- Remote monitoring via EDC
- ClinPro Trials experts will help you create your strategic clinical development plan, and provide tactical support to complete the following:
- Develop the clinical trial design
- Determine sample size calculations
- Write, edit or review protocols
- Design electronic Case Report Forms (eCRFs)
- Draft regulatory agency, board meeting, or investor presentations of the clinical development, regulatory and/or statistical plans
- Author Statistical Analysis Plans (SAP) or Interim analysis plans (IAP)
Patient Recruitment
The success of a clinical trial regardless of the Phase depends on patient recruitment and retention. We will diligently work with our global patient recruitment team in enrolling and retaining patients for your trial. ClinPro Trials has specific customised data-driven patient and community outreach efforts which include:
- Digital Media Campaigns
- Dedicated in-house call center
- Online Platforms
- Social media
- Targeted websites
- Study apps which have a targeted audience of patients looking for clinical trials
- Advocacy groups
- Physician Recruitment
- Participant education
- Study information sheets
- Developing IRB-approved pre-screening protocols
eTMF Management
ClinPro Trials offer a robust solution to managing your eTMF which is the lifeline of your study and forms the basis of your inspection. Over 90% of TMFs are inadequate at the end of the study and results in delays of regulatory approval. ClinPro Trial will partner with you throughout the lifecycle of your clinical program to ensure that your TMF is robust and meets the documentation requirements for each phase. Therefore by the time you get to the end of Phase 3, your TMF will be inspection ready. We have experienced TMF experts who will work with you continually throughout each phase to review, and issue reports of gaps in the TMF so that these can be mitigated. ClinPro Trials endorses the use of a cloud-based integrated eTMF solution which provides visibility and accountability for all parties involved such as the sites, sponsors and us.
Medical Writing
ClinPro Trials medical writing team will partner with you to prepare your clinical protocols, CSRs and all other clinical reports and documents that you need. Our Medical Writer will work in partnership with the Medical Monitor as well has Clinical and Regulatory compliance experts in authoring and delivering accurate and compliant materials.