Subject Matter Experts

Fractional SMEs are seasoned consultants who join your team part‑time or project‑based, providing the same knowledge and guidance as a full‑time hire without the long‑term overhead. You get access to their expertise when you need it and can scale the engagement up or down as your studies or business demands change.

We support every step of the vendor lifecycle—from drafting RFIs/RFPs and evaluating proposals to overseeing implementation and conducting ongoing performance reviews. Our experts know the IRT/RTSM and eCOA/ePRO landscape and can help you choose the right technology partner, mitigate risk and ensure your vendors meet regulatory and operational requirements.

We partner with clinical trial sponsors (pharmaceutical, biotech and medical device companies) as well as eClinical solution and service providers. Our consultants have deep experience across IRT/RTSM, eCOA/ePRO, CTMS and other eClinical technologies, so we understand the needs of both buyers and sellers in this space.

We’re flexible. Most clients choose a fractional or project‑based contract that defines the scope of work and a monthly or project fee. For smaller engagements or ad‑hoc advisory, we can work on an hourly basis. If you’re looking for a longer‑term functional service provider (FSP) arrangement, we can staff dedicated resources to act as an extension of your team for a fixed period. We’ll discuss your needs during the discovery call and recommend the structure that makes the most sense for your goals and budget.

BC Consulting’s eClinical SMEs can step in wherever you need them. Examples of the tasks we routinely handle include:

• User Acceptance Testing (UAT) – authoring UAT scripts, executing test cases, capturing results and ensuring that issues are resolved before go‑live.

• Documentation and process management – reviewing and approving specification documents (e.g. IRT functional specifications), writing and updating standard operating procedures (SOPs) and work instructions, and creating templates to standardise processes.

• System and risk assessments – conducting critical system reviews to assess compliance with 21 CFR Part 11 and other regulations, performing gap analyses across studies and systems, and developing risk matrices to highlight potential issues.

• Standards implementation – evaluating current practices against industry and regulatory standards, recommending improvements, and implementing harmonised workflows and checklists.

• Vendor and study oversight – supporting RFI/RFP processes, evaluating vendor proposals, overseeing configuration and change control, and providing day‑to‑day advisory support to study teams.

• Training and change management – training super users and end‑users on new processes, developing training materials, and guiding adoption through pilot studies.

Whether you need help with a single deliverable or a more comprehensive process redesign, our team can provide targeted, hands‑on support.