CRK-CRO is a leading Kenyan contract research organization
CRK‘s clinical trial management is cost-effective, client-focused, and flexible – allowing intimate control over study progress.
Our innovative study designs are aimed at exploiting scarce funding for early phase trials, employing expert strategy consultation and implementation.
We adhere to agreed targets with dedication and reliability; and present the resulting data accurately and comprehensively.
Centering on the patient and the site
Our services are made to minimize site efforts so that staff members can concentrate on patient care rather than logistical issues. Clinical trial enrollment rates are increased, patients have easier access to clinical trials, and home participation is made possible for decentralized studies thanks to CRK’s novel patient-centric recruitment strategy and site-centric management model working together.
- Regulatory Submissions
- Medical Writing
- Clinical Trial Management
- Clinical Trial Monitoring
- Data Management
- Quality Assurance
Our project managers supervise every important area of the study skillfully and meticulously to guarantee results delivery on schedule, under budget, and with the greatest possible output.
- Creating, gathering, and reviewing regulatory documentation
- Contracts for clinical studies and patient budgets are negotiated.
- Aware Consent Creating, Reviewing, Negotiating Languages, and Maintaining
- Work proactively on behalf of the sponsor with IRBs and competent authorities
- Reporting to Sponsor on a regular basis and in a timely manner
- In-house and On-site Monitoring
- Trial, Site, and Patient Management
- Site Consultation and Support
- Training on the Protocol, CRFs, SOPs, and ICH- GCP for CRAs and site staff.
- Continuous evaluation of CRA work to ensure the highest standards and coherence
- Controlling the budget and project schedules
Clinical Research Associates (CRAs) with extensive experience make sure the study adheres to the highest standards of patient safety and data integrity. At this time, we provide:
- Site Quality, Suitability, and Selection
- Closeout visits, routine monitoring, and support initiating
- Examination of source documentation and data validation
- Assistance for Regulatory Compliance and Review
- Presentation & Participation at Meetings of Investigators
- Finding and fixing protocol deviations and violations
- Reporting of Adverse Events & serious Adverse Events
- Study Supply Inventory
Our Clinical Data Management (CDM) personnel are dedicated to sustaining a consistent, process-driven approach from database creation through database lock.
- Complete and specialized data management support
- Data Form Collecting & Data Discrepancy Query
- Data Consolidation, Gathering, and Tracking
- Listing of Patients and Evaluation of Narratives
- Lab normal range, lesion cleaning, and SAE
- Clinical Scientists, Submission Support
- Patient Listing Review, Data Reconciliation, and Query Generation Team
CRK-CRO employs medical writers with scientific backgrounds, typically a master’s or Doctorate with certifications in chemistry, life sciences, or pharmacy. Also, they have prior expertise in a variety of therapeutic fields in pre-clinical research, clinical laboratory, study coordination, regulatory affairs, and data administration. Comprehensive medical writing services:
- Investigator Brochures
- Trial protocols and amendments
- Model informed consent forms
- Clinical Study Reports (CSRs)
- Literature Reviews
- Clinical Expert Reports
- Executive Summaries
- Journal Manuscripts and Abstracts
- + complementary DynaKin’s expertise in PK/PD
The most popular method of pharmacokinetic data analysis for studies with frequent sampling, both in pre-clinical and clinical research, is non-compartmental analysis (NCA). We employ the most recent validated software that has been approved by various regulatory agencies. In this situation, we supply:
- Creation, Collection and Revision of Data bases
- PK analysis requirements, including:
- Bioequivalence studies
- Drug-to-drug interactions
- Food interactions
- Gender and age impacts on the DMPK of drugs
- Dose and time linearity studies
- Generation of presentations with the preliminary results
CRK®’s clinical trial services advantage
Our team has extensive knowledge of the local population, customs, and culture, providing a valuable advantage for research projects in Kenya
Faster the time to market for your clinical trial is not only an important scientific advancement, but also a vital breakthrough that could save lives. To get there, your team needs to strike a balance between current research and the needs of equipment, multi-vendor management, tight international standards, process and protocol requirements, and budget and deadline goals.
Clinical research is fueled by our quality, variety, knowledge, personalization, and ease.
You can rely on our end-to-end capabilities to maximize your clinical study because our receptive, knowledgeable teams will make sure you have what you need, when and when you need it:
- Custom kitting solutions
- Clinical trial equipment and ancillary solutions
- Bio repository & archiving services
We offer competitive pricing without sacrificing quality or reliability
- Quality – We are dedicated to providing our clients with high-quality research services that meet the highest standards of accuracy, reliability, and ethical conduct. We take pride in delivering results that can be trusted and relied upon.
- Innovation – We strive to remain at the forefront of research innovation by adopting the latest technologies, methodologies, and practices. We continuously evaluate our processes and procedures to identify opportunities for improvement and stay ahead of the curve.
- Ethics – We are committed to upholding the highest ethical standards in our research practices. We prioritize patient safety, data integrity, and confidentiality in all aspects of our work.
- Collaboration – We believe that strong partnerships are key to achieving successful research outcomes. We work closely with our clients to understand their unique needs and tailor our services to meet those needs. We also foster collaborative relationships with local healthcare providers and communities to ensure that our research is sensitive to local customs and practices.
- Proposal for Added Value – Expert, high-caliber support with a customized approach. Tailored service, consistency and expertise not always found in a larger organization.
- Flexibility – CRK clinical research key is able to scale back or fast ramp up operations while maintaining a trained workforce pool thanks to strategic collaborations. When an agreement is reached, our team can immediately begin the major project work, often in as little as 24 hours.
- Innovation – Regularly develop and put into practice new processes, as well as enhance current client procedures.
- Big Picture Approach –Cross-functional, results-driven team members offer more perspective and comprehension of the projects as a whole, rather than just as individual tasks.
Be the first to know about our initiatives, news and other related information
We prioritize the needs of our patients in everything we do. Getting better, more efficient treatment options to the people who need them is our goal, whether we’re working on a small, intensive proof-of-concept research or a massive, worldwide clinical trial.