We offer comprehensive clinical trial services in support of Phase II, III and IV studies. Our dedicated team of experts offer you what we do best in meeting your specific needs. Take a look at the services that we offer here at Klinsel.

ResearchIn THREE Steps

Make your work easier with the holistic approach of services that we offer.

Study Setup

Study Conduct

Study Closeout

STUDY SETUP

FEASIBILITY STUDIES

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

PROTOCOL DESIGN & WRITING

  • Preparing of study protocol defining medical issues
  • End-point measurement issues
  • Trial statistical design and sample size planning
  • Study drug administration
  • Study procedures

CONTRACT & BUDGET

Drafting of proposals for securing of grants particularly for investigators initiated trials.

STUDY INITIATION

  • To initiate the research according to schedule.
  • We can help in the planning and coordinating of the 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 reviewing the sufficiency of resources at site. Preparation of the investigator study package for each site is essential.
  • Study drug administration
  • Study procedures

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, distribute and manufacture study drugs for investigational use.

STUDY CONDUCT

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

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.

CLINICAL TRIAL LOGISTICS

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

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
    • Proper study documentation and records maintenance
    • Resolving data queries
STUDY CLOSEOUT

SITE CLOSEOUT

When the study research is completed or discontinued, our team will conduct final site closeout, compile all the required documents and related clinical trial supplies for drugs and non drugs including investigational products reconciliation.

COMPILATION OF CENTRAL FILE & ARCHIVING

Indexing the content of the trial master file to be archived. Provide assistance/recommend professional vendors for storage and archiving of clinical trial related documents.

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