Services

Clinical Trial Management (CTM)

Drug and Device Trial Management

  • Management of Phase I to IV trials on proof of concept or small scale trials on drugs, biologics, and devices
  • Designed for publication to peer-reviewed journals or to support the decision to pursue large scale FDA registration trials
  • Compliance with applicable requirements such as Data Privacy Laws, Good Clinical Practice, and applicable regulatory requirements and guidelines
  • Services include protocol development, regulatory affairs services, monitoring, data management and analysis, and report writing

Post Marketing Surveillance (PMS) and Real World Evidence (RWE)

  • Post Marketing Surveillance (PMS) and Real World Evidence (RWE) studies end to end support from pre-regulatory and start-up to close-out and clinical study data analysis reporting.
  • Compliance with applicable requirements such as Data Privacy Laws, Good Clinical Practice, and applicable regulatory requirements and guidelines
  • Services include protocol development, monitoring, data management and analysis, and report writing

Site Management Organization (SMO)

Our 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, including:

Capabilities

  • 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

 

Clinical Trial Support Services (CTSS)

We supply extensive support for pre- and post-marketing trial activities – powered by experienced partner-providers for pharmacovigilance and clinical data management – ensuring that your trials deliver and comply with current regulatory standards.

Pharmacovigilance and/or Drug Safety Surveillance (PV)

We support your PV with end-to-end project management, including:

  • Processing of adverse-event case reports and conducting follow-up
  • Appropriate notification of regulatory agencies and business partners
  • Responding to requests from regulatory agences
  • Review of scientific literature and bibliographic source
  • Assistance in drafting and managing periodic safety-update reports
  • Evaluation of safety profiles
  • Ensuring proper document filing and archiving
  • Responding to requests from regulatory agences

  • End-to-end 24 hour monitoring and aggregate regulatory reporting service
  • Complemented by a EMA and US FDA compliant software
  • Highly experienced staff in adverse event (drug, device, cosmetic) case intake, triage, case processing, CIOMS form generation, regulatory reporting, and submission
  • Available for Medicinal Products and Medical Devices (including technical complaints)
  • Pharmacovigilance Training (for internal employees and affiliates)
  • Audit & Inspection Preparation and Readiness Program (including System and SOP audit)

 

Medical Writing

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

Regulatory Affairs Assistance

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.

Investigator-Initiated Research (including registries)

  • 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

Bioavailability (BA) and Bioequivalence (BE) Studies

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

Experienced staff capable in conducting the following trainings:

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