Services

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

*In Europe, these specific items are often performed by the Sponsor or CRO, rather than the SMO.

Monitoring and 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

Monitoring

Our pool of experienced clinical trial professionals ensure that the trial is conducted according to the clinical investigational plan and applicable requirements.

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.

Medical Writing

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

Medical Monitoring

Serving as the medical expert for assigned clinical trials, this service provides input on the design and conduct of clinical trials, assessment and interpretation of clinical data, and will contribute to investigator training, including good medical and clinical practices.