Reference · 22 terms

Clinical & life-science vendor glossary

Plain-English definitions covering CRO/CDMO vendor types, regulatory submissions, biostatistics, and eClinical technology — the procurement vocabulary that governs clinical and life-science vendor sourcing. Written for buyers who need the vocabulary before a first call.

CDMO & Manufacturing 6

Biosimilar

A biologic drug product that is highly similar to, and has no clinically meaningful differences from, an already-approved reference biologic (the originator product), approved through an abbreviated regulatory pathway once the reference product's exclusivity period ends. Manufacturing a biosimilar is technically demanding because, unlike small-molecule generics, biologics cannot be manufactured as an exact chemical copy.

See: cdmo cmo selection guide pharma

CDMO (Contract Development and Manufacturing Organization)

Also: Contract Development & Manufacturing Organisation

A company that both develops a drug's manufacturing process (formulation, analytical methods, scale-up) and then manufactures the drug substance or drug product under current Good Manufacturing Practice (cGMP) conditions on a sponsor's behalf. A CDMO's development work is what distinguishes it from a pure CMO, which typically only manufactures a process the sponsor has already developed.

See: cdmo cmo selection guide pharma

CMO (Contract Manufacturing Organization)

Also: Contract Manufacturing Organisation

A company that manufactures a drug substance or drug product on behalf of a sponsor using a manufacturing process the sponsor has already developed and validated, without necessarily providing process development services itself. Many manufacturers today market themselves as CDMOs even for engagements that are, strictly speaking, CMO-only manufacturing work.

See: cdmo cmo selection guide pharma

Fill-Finish

Also: Fill and finish

The final stage of drug product manufacturing in which the bulk drug substance is aseptically filled into its final container, such as a vial, syringe, or cartridge, then sealed, inspected, and packaged. Fill-finish is a distinct, often specialized manufacturing capability, particularly for sterile injectable and biologic products, and was a major bottleneck during COVID-19 vaccine manufacturing.

See: cdmo cmo selection guide pharma

GMP (Good Manufacturing Practice)

Also: cGMP, Current Good Manufacturing Practice

A system of regulations, procedures, and documentation requirements that pharmaceutical manufacturers must follow to ensure products are consistently produced and controlled to quality standards, covering facilities, equipment, personnel training, and record-keeping. In the US, cGMP (current Good Manufacturing Practice) is enforced by the FDA under 21 CFR Parts 210 and 211; manufacturing sites are periodically inspected against it.

See: cdmo cmo selection guide pharma

Technology Transfer

Also: Tech transfer

The formal process of transferring a manufacturing process, along with its analytical methods and documentation, from one site or organization to another, such as from a sponsor's development lab to a CDMO's commercial manufacturing facility. A poorly managed technology transfer is a common source of manufacturing delays and batch failures.

See: cdmo cmo selection guide pharma

CRO & Trial Operations 4

CRO (Contract Research Organization)

Also: Contract Research Organisation

A company hired by a pharmaceutical, biotech, or medical device sponsor to run some or all of a clinical trial on its behalf: protocol design, site management, patient recruitment, monitoring, data management, and regulatory submission support. CROs range from large, full-service global organizations to small firms specializing in a single therapeutic area or trial phase.

See: clinical research organization buyer guide

DMC (Data Monitoring Committee)

Also: DSMB, Data Safety Monitoring Board

An independent group of experts, separate from the trial's sponsor and operational team, that periodically reviews unblinded interim safety and efficacy data during a trial to recommend whether it should continue, be modified, or stop early. A DMC (also called a DSMB, Data Safety Monitoring Board) is especially common in trials with long durations or higher patient-safety risk.

See: biostatistics consulting buyer guide

FSP (Functional Service Provider)

Also: Functional service provider model

An outsourcing model in which a vendor embeds a specific clinical trial function, such as monitoring, data management, or biostatistics, directly into the sponsor's own team and processes, rather than managing an entire trial end to end the way a full-service CRO does. Sponsors with an ongoing trial portfolio often use the FSP model to scale a specific function consistently across studies.

See: clinical research organization buyer guide

Site Feasibility

Also: Feasibility assessment

The process of evaluating whether a clinical trial site (a hospital, clinic, or research center) has the patient population, staff, and infrastructure to successfully enroll and run a specific trial before it is formally selected. Feasibility assessments typically review prior enrollment performance, investigator experience, and competing trials at the same site.

See: clinical research organization buyer guide

eClinical & Data 5

Database Lock

Also: Data lock, Hard lock

The point at which a clinical trial's data is finalized, verified, and access is frozen so no further changes can be made, marking the transition from data collection and cleaning to statistical analysis. Database lock is typically preceded by a formal data-cleaning and query-resolution period and requires sign-off from data management, biostatistics, and often the sponsor.

See: clinical data management vendor guide, biostatistics consulting buyer guide

eCOA / ePRO

Also: electronic Clinical Outcome Assessment, electronic Patient-Reported Outcome

Electronic tools used to collect clinical outcome assessments directly from trial participants (ePRO, electronic patient-reported outcomes) or clinicians/observers (eCOA more broadly), such as symptom diaries or quality-of-life questionnaires, typically via a mobile app, tablet, or web portal rather than paper forms.

Related: EDC (Electronic Data Capture)

See: clinical data management vendor guide

eConsent

Also: Electronic informed consent

A digital version of the informed consent process, allowing trial participants to review consent materials, including interactive multimedia, and provide a legally valid electronic signature remotely or on-site, rather than signing a paper consent form. eConsent has become more common alongside the broader shift toward decentralized and hybrid clinical trials.

See: clinical data management vendor guide

EDC (Electronic Data Capture)

Also: Electronic data capture

Software used to collect clinical trial data electronically directly from investigator sites, replacing older paper case report forms. EDC systems are typically built for a specific trial's data-collection forms and include built-in edit checks and query management to help catch data errors during, rather than after, entry.

See: clinical data management vendor guide

IRT / RTSM

Also: Interactive Response Technology, Randomization and Trial Supply Management

Software that manages patient randomization to treatment arms and tracks investigational drug supply and inventory across trial sites, historically called Interactive Voice/Web Response (IVRS/IWRS) and now more often called IRT or RTSM (Randomization and Trial Supply Management). It ensures blinding is preserved while keeping enough drug supply at each site without over-shipping expensive investigational product.

Related: EDC (Electronic Data Capture)

See: clinical data management vendor guide

Regulatory & Biostatistics 7

21 CFR Part 11

Also: Part 11

The FDA regulation that establishes the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records for regulated industries, including clinical trial data systems. An EDC or eClinical vendor's Part 11 validation package is one of the first things a buyer should ask for before committing to a platform.

See: clinical data management vendor guide

BLA (Biologics License Application)

The formal application a sponsor submits to the FDA seeking approval to market a biologic product, such as a monoclonal antibody, vaccine, or cell/gene therapy, in the United States. A BLA plays the same role for biologics that an NDA plays for small-molecule drugs, and typically requires additional manufacturing and characterization data given the inherent complexity of biologic products.

See: biostatistics consulting buyer guide

GCP (Good Clinical Practice)

Also: ICH-GCP, ICH E6

An international ethical and scientific quality standard, set out in ICH E6, for designing, conducting, recording, and reporting clinical trials that involve human subjects. GCP compliance protects the rights, safety, and wellbeing of trial participants and ensures the credibility of the resulting trial data; it is the baseline requirement most CROs and sponsors are contractually and legally bound to follow.

See: clinical research organization buyer guide

IND (Investigational New Drug Application)

An application a drug sponsor must submit to and receive clearance from the FDA before it can legally ship an investigational drug across state lines to begin human clinical trials in the United States. An IND includes preclinical safety data, manufacturing information, and the proposed clinical trial protocol; the EU equivalent is a Clinical Trial Application (CTA).

See: clinical research organization buyer guide, biostatistics consulting buyer guide

NDA (New Drug Application)

The formal application a sponsor submits to the FDA seeking approval to market a new small-molecule drug in the United States, containing the full record of preclinical and clinical data, manufacturing information, and proposed labeling. The biologics equivalent of an NDA is a BLA (Biologics License Application).

See: biostatistics consulting buyer guide

Pharmacovigilance (PV)

Also: PV, Drug safety monitoring

The science and set of activities related to detecting, assessing, understanding, and preventing adverse effects or other drug-related problems, both during clinical trials and after a drug reaches the market. Pharmacovigilance obligations continue for the life of an approved product, and many regulatory affairs consultancies offer it as a dedicated practice alongside submission strategy.

Related: GCP (Good Clinical Practice)

See: biostatistics consulting buyer guide

SAP (Statistical Analysis Plan)

Also: Statistical analysis plan

A detailed technical document, finalized before a trial's database lock, that specifies exactly how the collected data will be statistically analyzed: the primary and secondary endpoints, the statistical methods and models, handling of missing data, and any planned interim analyses. Regulators expect the SAP to be locked before unblinding to prevent analysis choices from being influenced by the results.

See: biostatistics consulting buyer guide

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