From Strategic Consulting to Full-Service Project Delivery

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 At BioClinical Solutions, we specialize in LEAN, TRANSPARENT, and SCALABLE IND-enabling support that bridges scientific innovation with operational precision.

We guide sponsors seamlessly from Pre-IND through Phase I/II  

• GAP Analysis
• Pre-IND Preparation & Meeting Support
• IND Submission
• Planning and execution for Phase 1 & 2

Expertise in creating trial and operational strategies to ensure rapid start up and enrolment within timelines and budget, while meeting your primary protocol objectives: 

• Clinical protocol design & writing
• Study plan strategy and design
• Operational strategy and plan development
• Vendor identification and selection
• Project performance

Our experts focus on merging proven operational strategies with innovation, efficiency and speed resulting in quality by design. Let our experts support your teams in 

• Project lifecycle management
• Expedited start up
• Project maintenance management
• Vendor selection, start up and management
• Monitoring services and strategies
• Risk and issue mitigation
• Quality and inspection readiness
• Close out management

With over 13 years of DCT expertise overseeing over 200 DCT studies globally and expertise in building world class DCT and HHC divisions, first in class technology builds and trial implementation, let our DCT experts support you in building and operationalizing your DCT strategy or clinical trial. 

• Strategy and design
• Operational management and support
• Patient recruitment strategies
• Vendor identification and management
• In-house DCT training
• Quality and inspection readiness

Not all studies will go to plan, e.g. it is will documented that patient recruitment and retention can cause delays. This has an impact on both timelines and budget.  It is important to quickly understand the underlying issues and develop an action plan to get back on track.

Our experts have the experience to support you with:

• Rapid root cause analysis
• Delivering a plan to rectify performance barriers
•  Overseeing the delivery of the agreed plan to drive enhancements to get your project back on track 

 Capitalize on proven pharmaceutical and CRO experience to expand and improve your organization with either service or geographical expansion. We can help you drive your operation to the next level of excellence across all levels. 

• Corporate service expansion
• Global or regional service expansion
• Financial performance improvement
• Departmental and Corporate Operational Excellence
• Operational execution analysis and improvement
• Process enhancement and SOP development

With extensive pharmaceutical industry experience, our experts have led 500+ clinical trials and 500 + audits resulting in successful NDA submissions, our experts know inspection readiness is critical. Planning for high quality project delivery and patient safety is imperative. Let our quality experts ensure your clinical trials are up to the 

highest standards

• Qualification audits
• Inspection readiness
• TMF audits
• PM audits
• Site audits
• Quality plan development
• Risk and issue plan development
• Mock inspections