OUR SERVICES

We offer comprehensive clinical trial services in support of Phase II, III and IV studies. Our dedicated team of expertise offers you what we do best in meeting your specific needs:

• PROTOCOL DESIGN & WRITING
  Preparing of study protocol defining medical issues, end-point measurement issues, trial statistical design and sample size planning, study drug administration and study procedures.

• CONTRACT & BUDGET
  Drafting of proposals and securing of grants particularly for investigators initiated trials.

• FEASIBILITY STUDIES
  Perform in-depth feasibility studies to ensure a team of experienced clinical investigators with access to the relevant patient population for your research.
  Study site selection and qualification can be time consuming, Klinsel acts as an interface between a sponsor and potential sites hence assuring a smooth and timely process of identifying competent sites and investigators at the very start of your research.

• STUDY INITIATION
  To initiate the research according to schedule is frequently limited by logistics and technical factors.
  We can help in the planning and coordinating of investigators meetings prior to the conduct of site initiation visits.
  
  Our focus in initiating the study at sites is the people – providing protocol specific training to site personnel and reassuring the sufficiency of resources at site and this includes preparing of investigator study package for each site.

• PROJECT MANAGEMENT
  We assign a Project Manager as a single point of responsibility, supported by a multi-disciplinary team to ensure on time and on budget project delivery, from initiation right up the closeout of your study.

•  IRB & REGULATORY AFFAIRS
  Preparation and submission for ethics approval by the relevant Ethics Committee as well as securing relevant licenses required by local regulatory authorities to import and manufacture study drugs for investigational use.

• TRIAL MONITORING
  Our qualified and trained monitors ensure a trial is conducted efficiently in accordance with the protocol, and in compliance with GCP, regulatory as well as other applicable requirements.

• SITE MANAGEMENT
  We believe that a successful research can be very much dependent on the performance of a study site hence efficient site management is essential. Our services in this area include:


• Training of investigators and study coordinators
• On-site assistance in regards to
• Patient recruitment strategies
• Visit scheduling
• Safety reporting
• Laboratory procedures
• Maintaining study documentation
• Resolving data queries

• SAFETY SURVEILLANCE/MONITORING
  Establish all required QC for this critical function of assuring compliance to GCP and regulatory requirements and most importantly, consideration of the safety and wellbeing of research patients.
  Our services in this area focus on monitoring, management and reporting of adverse events, and these include:


• Adverse Event and Serious Adverse Event review
• Narrative preparation, and diligent follow-ups for incomplete reporting information
• Timely submission of safety reports to applicable authorities  

• CLINICAL TRIAL LOGISTICS
  Liaisons with reputable corporations, we ensure proper management of clinical trial logistics, which includes the clinical supplies chain as well as laboratory services.
  
  Ensures smooth supply and distribution chain of clinical trial supplies, i.e. from import, storage and handling to distribution, final reconciliation and destruction.
  
  Ensures proper biological specimen samples handling procedures and traceability of specimens as well as timely reporting of results.

• MEDICAL WRITING
  Our experienced team of medical writers provides assistance in the drafting of clinical trial report, manuscript and abstract.  

• ARCHIVING
  Provide assistance/recommend appropriate vendors for archiving of clinical trial related documents.

Should you have any questions, please do let us know......