Clinical trials services

• Added Value proposal – High quality, specialized support with a personalized approach. Tailored service, consistency and expertise not always found in a larger organization.
• Flexibility – Through strategic partnerships, DynaKin has the ability to ramp up quickly or scale back and maintain a skilled staff pool. Once the agreement is in place, our team is able to start up the main project work inmediately, sometimes in less than 24 hours.
• Innovation – Routinely create and implement new processes and/or improve upon existing client processes.
• Big Picture Approach – Results-driven, cross-functional team members provide greater insight and understanding of the projects as a whole, not just as designated tasks.

• Regulatory Submissions
• Medical Writing
• Clinical Trial Management
• Clinical Trial Monitoring
• Data Management
• Quality Assurance

Medical writers at Dynakin hold scientific degrees -usually a master’s or PhD with qualifications- in pharmacy, life sciences or chemistry. The also gather previous experience in pre-clinical research, clinical laboratory, study coordination, regulatory affairs, and data management in many therapeutic areas. Medical writing comprehensive 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

Our Project Managers work effectively and diligently to manage all critical aspects of the study to ensure on-time delivery of results, within budget and with the highest quality output.

• Creation, Collection & Review of Regulatory Documentation
• Negotiation of Clinical Study Contracts & Patient Budgets
• Informed Consent Creation, Review, Language Negotiation & Maintenance
• Work Directly with IRBs and Competent Authorities on Behalf of Sponsor
• Frequent and timely reporting to Sponsor
• Trial, Site and Patient Management
• In-house and On-site Monitoring
• Site Consultation & Support
• Training for CRA-s and site personnel on the protocol, CRF-s, SOP’s, ICH- GCP.
• Constant review of CRA-s work to assure highest standards and consistency
• Management of Budget and Project Timelines

Highly experienced Clinical Research Associates (CRAs) ensures the study is met with the highest standard of patient safety and data integrity. At this stage we offer:

• Site Feasibility, Qualification & Selection Support
• Initiation, Routine Monitoring & Closeout Visits
• Source Documentation Review & Data Verification
• Regulatory Compliance Support & Review
• Participation & Presentation at Investigator Meetings
• Identification & Addressing of Protocol Deviations & Violations
• Study Supply Inventory
• Reporting of Adverse Events & Serious Adverse Events

From database creation to database lock, our Clinical Data Management (CDM) professionals are committed to upholding a standardized, process-driven approach.

• Full and Niche Data Management Support
• Data Discrepancy Query & Data Form Collection
• Data Reconciliation, Collection, Tracking
• Patient Listing and Narrative Review
• SAE, Lab Normal Range & Lesion Cleaning
• Clinical Scientist & Submission Support
• Narrative Review/QC, Patient Listing Review, Data Reconciliation, Query GenerationTeam

Non-compartmental analysis (NCA) is the most commonly used technique of pharmacokinetic data analysis for studies with frequent sampling, both in pre-clinical and clinical studies. We use the latest validated software Phoenix® WinNonlin® accepted by the different Regulatory Agencies. At this state we offer:

• 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
  • Etc.
• Generation of presentations with the preliminary results
• Reporting