PiVOT’s Site Management Organization (SMO) platform provides contract research organizations (CROs), pharmaceutical and biotechnology companies, medical device companies, and especially clinical investigation sites – our critical partners – with excellent clinical-trial-related services.

• Contract negotiations
• Submission for Institutional Review Board or Independent Ethics Committee (IRB/IEC) approval
• Patient counseling
• Patient recruitment and retention
• Patient follow-up
• Informed Consent Form (ICF) translation into vernacular languages*
• Site initiation and trial close-out operations
• Trial-related documents archival and maintenance
• Reporting serious adverse events to the Sponsor or CRO and the IRB/IEC
• Ensuring protocol compliance
• Advising and alerting investigators of potential protocol violations
• Advising and alerting investigators of potential ICH-GCP violations
• International site accreditation and training
• Networking of research sites

Our services and project management leads can consult and work with biostatistical, PV, project management, and data management teams to generate accurate, time-efficient, cost-effective documents that comply with the highest bioethical and scientific standards.

• Accomplishing Company and Drug-focused Risk Management Plans
• Develop drug-focused reports for inclusion into the National or Institutional Formularies
• Study reports required by regulatory authorities
• Writers are experienced in writing journal publications, Philippine National
• Formulary applications, and ICH-guided study reports to FDA

Our specialization in clinical research regulation allows us to offer consulting assistance in conducting relevant regulatory submissions, as well as to liaise on behalf of our business partners with the relevant competent health regulatory authorities.

We help the Filipino researcher write grants and manage the research to reach deliverables set by the grant agencies. Our team of experienced individuals can advise researchers on grant application, research contract negotiations, intellectual property protection and management, technology transfer, and commercialization.

• GLP Certified BA/BE Partner in Malaysia
• Accredited by the USFDA and the French Regulatory Authority (ANSM)

• Good Clinical Practice (GCP)
• Good Manufacturing Practice (GMP)
• Good Pharmacovigilance Practice (GPVP)