Clinical Research
Clinical Research
Crystal Biological Solutions has rich experience, vast knowledge, advanced technologies and IT powered processes to conduct clinical studies. With strong local know-how and several years of international regulatory experience, Crystal Biological Solutions is your right partner for conducting clinical research studies in India. Our expertise and leadership in Preclinical/Non-clinical testing studies over the years has been extended to offer wider range of clinical research services such as clinical end point studies, claim studies for cosmetics and consumer care products, BA/BE studies and clinical studies for complex neutraceuticals.
Services :
- Clinical Trial Management
- Project Management
- Clinical Trial Monitoring
- Study Feasibility
- Patient Recruitment
- Medical Writing
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Clinical Trial Management
LBPL optimizes study operations, saves costs and stays compliant for planning, conducting and monitoring your study.
- Manage the study start-up activities
- Ethics Committee coordination
- Faster patient recruitment
- Clinical trial supply management
- Documentation
- Leadership
- Trial oversight
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Project Management
One point of contact. With you every step of the way.
- Develop the project plan and timeline
- Select and manage vendors
- Start-up activities and study initiation
- Oversee study conduct and clinical monitoring
- Manage data support teams from protocol development to clinical study report
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Clinical Trial Monitoring
- Crystal Biological Solutions has skilled and well-trained clinical research associates (CRAs) to ensure the highest quality review of data and effective interaction with study sites.
- Our CRAs will conduct on-site monitoring visits throughout the study to oversee data collection, ensure regulatory compliance, resolve data queries and review source documentation and CRFs.
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Study Feasibility
- Acceptability of the study from scientific, regulatory and ethical perspectives.
- Accessibility to specific equipments.
- Expediting of your study.
We at Crystal Biological Solutions conduct different types of feasibility
- Study Feasibility
- Site or investigator level feasibility
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Patient Recruitment
Crystal Biological Solutions provides solutions for patient recruitment for clinical trials as detailed below :
- Providing highly qualified referrals that can be converted into randomized patients, boosting your enrollments by as much as 30-50%
- Utilizing our efficient processes and advanced tools rather than adding more sites
- Crystal Biological Solutions site relationship managers will work hand-in-hand to maximize patient enrollment and expedite your studies
- Crystal Biological Solutions gives you experienced staff and tools needed to keep patients engaged and active so you don’t have to revisit the recruitment phase.
- Provides Patient education materials and notifications written in local languages to help motivate patients to complete your study
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Medical writing :
Medical Writing at Crystal Biological Solutions includes regulatory and clinical writing services including peer-review publications. We have expertise in developing scientific documents in accordance to the SOPs and customized as per sponsor’s requirements that comply to ICH GCP guidelines.
- Protocol Design & Development
- Clinical Study Report
- Customized as per sponsor’s requirements
- Informed Consent Forms
- Periodic Safety Update Reports
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