Supplemental Oncology Clinical Development Services

Some large pharmaceutical and biotech companies prefer to have a specialty oncology CRO available to handle specific tasks during their study.

Whether it’s to support their in-house team, bring specific expertise to the table, or provide a second set of eyes on the lead CRO’s work, Medelis can provide these services a la carte or under a master services agreement.

Below are some of the services we currently provide. Contact us if you’re interested in one of these services or to discuss a different service.

  • EXPERT CLINICAL DATA REVIEW
    Experts provide extensive data review on studies in complicated indications. Review can include items such as inclusion/exclusion criteria, efficacy data, adverse event and serious adverse events, SAE reconciliation, lab parameters, and protocol deviations.
  • REGULATORY
    Flexible services ranging from specific regulatory questions to writing, compiling and filing regulatory submissions to setting up and leading regulatory meetings on behalf of the sponsor. Can assist with collecting and preparing study-specific SOPs and regulatory documents for the regulatory agencies in the US and Europe.
  • SAFETY REPORTING AND PHARMACOVIGILANCE
    Global safety expertise in all phases of clinical research for Serious Adverse Event/Adverse Event (SAE/AE) collection, evaluation, classification, reporting, and reconciliation. SAE narrative writing and SAE narrative review, along with a 24/7 drug safety hotline to meet stringent timelines for regulatory compliance and SAE follow-up.
  • MEDICAL WRITING
    Comprehensive medical writing for study-specific services for protocols, INDs and investigator brochures, clinical study reports, regulatory briefing documents, clinical safety & efficacy summaries, abstracts for professional meetings, presentations for FDA and other regulatory meetings and manuscripts.
  • SITE AND PATIENT MONITORING
    Monitoring of sites and patients, which includes verification of adherence to protocol (with particular attention to SAE reporting, informed consent procedure, and laboratory assessments), a check of regulatory file maintenance, drug accountability, and 100% source documentation verification. Also includes review of facilities and staffing changes and assessment of patient enrollment with recommendations.
  • MEDICAL MONITORING
    Medical management and oversight on sponsor’s behalf, using a board-certified clinical oncology specialist to work closely with site investigators and sponsor’s own experts.
  • PROJECT MANAGEMENT
    Dedicated project manager to facilitate communication and regularly assess timelines, metrics, performance and critical actions/challenges/solutions for the project.
  • INVESTIGATIVE SITE AUDITS
    Site audits led by our Quality Director to assess compliance with the protocol, Good Clinical Practices, applicable Standard Operating Procedures and regulations.

Start a conversation with us to share what you’re looking for and see if we might be a fit.