Additional Services

Statistics & Medical Writing

Every trial requires expert statistical and medical writing leadership. From study design to CSR delivery, we offer a full range of services to transform study data into actionable information.

Statistical & Medical Writing services include:

  • Study design and protocol development.
  • Randomization design.
  • Statistical Analysis Plan (SAP) creation.
  • Statistical programming support.
  • Data analysis.
  • Pharmacokinetic and pharmacodynamic analysis and modeling.
  • SDTM/ADaM dataset and TLG/TLF preparation.
  • Clinical Study Report (CSR) creation.

Study Rescue / Cleanup Services

In a pinch, we offer specialized study rescue/cleanup services to get your trial back on track if it has fallen behind schedule, you are experiencing problems with data quality, or costs are out of control. We can take over management of your trial at any point and rapidly rectify the problems that your trial is facing.

Regulatory Strategy and Support

Development of regulatory submissions strategy and implementation of regulatory-compliant submissions processes.

FDA Submissions

Paper and eCTD-based regulatory compliant document authoring, management, preparation, and publishing services.

Investigator Site Audits

Services include:

  • Verification of source documents and data collected.
  • Informed consent processes and documentation.
  • Adherence to company and institutional SOPs.
  • Compliance with FDA regulations, GCP Guidelines and protection of human research subjects.
  • Review of site procedures.
  • IRB Audits.
  • Quality systems audits.
  • Investigator selection and qualifications.
  • Study conduct.

We also perform CRA audits, CRO audits, and on-site audits of your vendors and suppliers.

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