{"id":5211,"date":"2024-11-03T17:15:25","date_gmt":"2024-11-03T09:15:25","guid":{"rendered":"https:\/\/klinsel.com.my\/v4\/?page_id=5211"},"modified":"2024-11-03T17:16:04","modified_gmt":"2024-11-03T09:16:04","slug":"our-services","status":"publish","type":"page","link":"https:\/\/klinsel.com.my\/v4\/our-services\/","title":{"rendered":"Our Services"},"content":{"rendered":"

<\/div>

Our<\/span> Services<\/span><\/h1>\n

We offer comprehensive clinical trial services in support of Phase II, III and IV studies.<\/span><\/p>\n<\/div>

<\/div><\/div><\/div><\/div><\/div>

Study Setup<\/h3>\n<\/div>
<\/span><\/div>
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Feasibility studies, protocol design & writing, contract & budget, study initiation, project management, IRB & regulatory affairs<\/p>\n<\/div>

<\/div>
LEARN MORE<\/span><\/a><\/div><\/div><\/div>

Study Conduct<\/h3>\n<\/div>
<\/span><\/div>
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Safety surveillance\/monitoring, trial monitoring, clinical trial logistics, site management<\/p>\n<\/div>

<\/div>
LEARN MORE<\/span><\/a><\/div><\/div><\/div>

Study Closeout<\/h3>\n<\/div>
<\/span><\/div>
<\/div>

Site closeout, compilation of central file
\n& archiving<\/p>\n<\/div>

<\/div>
LEARN MORE<\/span><\/a><\/div><\/div><\/div><\/div><\/div>

STUDY SETUP<\/h2>\n<\/div><\/div><\/div><\/div><\/div>

FEASIBILITY STUDIES<\/h3>\n<\/div>
  • <\/i><\/span>
    Perform in-depth feasibility studies to assure of a team of experienced clinical investigators with access to the relevant patient population.<\/div><\/li>
  • <\/i><\/span>
    Conduct pre-study site qualifications to evaluate suitability & enrollment potential<\/div><\/li>
  • <\/i><\/span>
    Comprehensive database in identifying & selecting sites competent for your research<\/div><\/li><\/ul>

    PROTOCOL DESIGN & WRITING<\/h3>\n<\/div>
    • <\/i><\/span>
      Protocol design defining clinical issues, study population and end-point measures<\/div><\/li>
    • <\/i><\/span>
      Trial statistical design and sample size planning<\/div><\/li>
    • <\/i><\/span>
      Study drug administration<\/div><\/li>
    • <\/i><\/span>
      Study procedures<\/div><\/li><\/ul>

      CONTRACT & BUDGET<\/h3>\n<\/div>
      • <\/i><\/span>
        Assist in site contract & budget negotiation.<\/div><\/li><\/ul><\/div><\/div>

        STUDY INITIATION<\/h3>\n<\/div>
        • <\/i><\/span>
          To initiate the research according to schedule<\/div><\/li>
        • <\/i><\/span>
          We can help in the planning and coordinating of the investigators meetings prior to the conduct of site initiation visits<\/div><\/li>
        • <\/i><\/span>
          Our focus in initiating the study at sites is the people \u2013 providing protocol specific training to site personnel and reviewing the sufficiency of resources at site<\/div><\/li>
        • <\/i><\/span>
          Study drug administration<\/div><\/li>
        • <\/i><\/span>
          Study procedures<\/div><\/li><\/ul>

          PROJECT MANAGEMENT<\/h3>\n<\/div>
          • <\/i><\/span>
            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 to completion.<\/div><\/li><\/ul>

            IRB & REGULATORY AFFAIRS<\/h3>\n<\/div>
            • <\/i><\/span>
              Develop Informed Consent Form (ICF) and patient information sheet (PIS) to meet ethics and regulatory requirements<\/div><\/li>
            • <\/i><\/span>
              Submit your research for ethics approval by the relevant Ethics Committee<\/div><\/li>
            • <\/i><\/span>
              Secure relevant licenses required by Regulatory Authorities to import or manufacture study drugs for investigational use<\/div><\/li><\/ul><\/div><\/div><\/div><\/div>

              STUDY CONDUCT<\/h2>\n<\/div><\/div><\/div><\/div><\/div>

              SAFETY SURVEILLANCE\/MONITORING<\/h3>\n<\/div>
              • <\/i><\/span>
                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.<\/div><\/li>
              • <\/i><\/span>
                Monitoring, management and reporting of adverse events (AE)<\/div><\/li>
              • <\/i><\/span>
                Site management with matters related to SAE reporting<\/div><\/li>
              • <\/i><\/span>
                Narrative preparation, and diligent follow-ups for incomplete reporting information<\/div><\/li>
              • <\/i><\/span>
                Timely submission of safety reports to applicable authorities<\/div><\/li><\/ul>

                CLINICAL TRIAL LOGISTICS<\/h3>\n<\/div>
                • <\/i><\/span>
                  We liaise with reputable corporations to ensure proper management of clinical trial logistics, which includes the clinical supplies chain as well as laboratory services<\/div><\/li>
                • <\/i><\/span>
                  Ensure smooth supply and distribution chain of clinical trial supplies \u2013 from import, storage & handling to distribution, final reconciliation and disposal<\/div><\/li>
                • <\/i><\/span>
                  Ensure proper biological samples handling procedures and traceability of specimens as well as timely reporting of results<\/div><\/li><\/ul><\/div><\/div>

                  TRIAL MONITORING<\/h3>\n<\/div>
                  • <\/i><\/span>
                    Qualified and experienced monitor to ensure a trial is conducted efficiently in accordance with the protocol, and in compliance with GCP, regulatory as well as other applicable requirements.<\/div><\/li><\/ul>

                    SITE MANAGEMENT<\/h3>\n<\/div>
                    • <\/i><\/span>
                      We believe that a successful research can be very much dependent on the performance of a study site hence efficient site management is essential<\/div><\/li>
                    • <\/i><\/span>
                      \n

                      Planning and coordinating investigator meetings<\/p>\n<\/div><\/li>

                    • <\/i><\/span>
                      Conduct site initiation visits including preparing of investigator study package, providing site resources and protocol specific training for site personnel<\/div><\/li>
                    • <\/i><\/span>
                      Provide on-site assistance and responding to queries from initiation till the closeout of the study<\/div><\/li>
                    • <\/i><\/span>
                      \n

                      Assist with:<\/p>\n

                        \n
                      • Patient recruitment,<\/li>\n
                      • Visit scheduling,<\/li>\n
                      • Safety reporting, lab procedures,<\/li>\n
                      • Drug storage & accountability,<\/li>\n
                      • Resolving data queries and maintaining study documentation<\/li>\n<\/ul>\n<\/div><\/li><\/ul><\/div><\/div><\/div><\/div>

                        STUDY CLOSEOUT<\/h2>\n<\/div><\/div><\/div><\/div><\/div>

                        SITE CLOSEOUT<\/h3>\n<\/div>
                        • <\/i><\/span>
                          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.<\/div><\/li><\/ul>

                          MEDICAL WRITING<\/h3>\n<\/div>
                          • <\/i><\/span>
                            Provide assistance \/ recommend appropriate vendors in the drafting of clinical trial report, manuscript and abstract.<\/div><\/li><\/ul><\/div><\/div>

                            COMPILATION OF CENTRAL FILE & ARCHIVING<\/h3>\n<\/div>
                            • <\/i><\/span>
                              Provide assistance \/ recommend appropriate vendors for archiving of clinical trial related documents.<\/div><\/li><\/ul><\/div><\/div><\/div><\/div>
                              \"\"\/<\/div><\/div><\/div>
                              \"\"\/<\/div><\/div><\/div>
                              \"\"\/<\/div><\/div><\/div>
                              \"\"\/<\/div><\/div><\/div>
                              \"\"\/<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"100-width.php","meta":{"footnotes":""},"class_list":["post-5211","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/klinsel.com.my\/v4\/wp-json\/wp\/v2\/pages\/5211","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/klinsel.com.my\/v4\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/klinsel.com.my\/v4\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/klinsel.com.my\/v4\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/klinsel.com.my\/v4\/wp-json\/wp\/v2\/comments?post=5211"}],"version-history":[{"count":2,"href":"https:\/\/klinsel.com.my\/v4\/wp-json\/wp\/v2\/pages\/5211\/revisions"}],"predecessor-version":[{"id":5213,"href":"https:\/\/klinsel.com.my\/v4\/wp-json\/wp\/v2\/pages\/5211\/revisions\/5213"}],"wp:attachment":[{"href":"https:\/\/klinsel.com.my\/v4\/wp-json\/wp\/v2\/media?parent=5211"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}