Name: Summit for Clinical Ops Executives SCOPE
Start: 2027-03-01
End: 2027-03-04
Location: Rosen Shingle Creek

Event overview

Overview

SCOPE Summit 2027, taking place from March 1-4 at Rosen Shingle Creek in Orlando, Florida, is the 18th annual gathering of the clinical research community.

The event features 38 conference tracks and over 325 exhibitors, focusing on innovations in clinical trials.

TL;DR

1Dates and Venue: SCOPE Summit 2027 runs March 1-4, 2027, at Rosen Shingle Creek, Orlando, Florida.
2Scale and Focus: The event features over 325 exhibitors and 38 conference tracks dedicated to clinical research innovations.
3Organiser: Hosted by Cambridge Healthtech Institute, more information can be found at scopesummit.com.
4Buyer Authority: Attendees include clinical research professionals from pharma, biotech, and regulatory sectors.
5Entry: Registration is open now with early bird discounts available until October 2, 2026.

Why visit

Attendees will gain access to cutting-edge discussions, networking opportunities with industry leaders, and insights into the latest trends and technologies in clinical research. Dates and Venue: SCOPE Summit 2027 runs March 1-4, 2027, at Rosen Shingle Creek, Orlando, Florida. Buyer Authority: Attendees include clinical research professionals from pharma, biotech, and regulatory sectors.

Why exhibit

Exhibitors will showcase their innovations to a targeted audience of decision-makers, enhancing visibility and fostering valuable connections within the clinical research community. Scale and Focus: The event features over 325 exhibitors and 38 conference tracks dedicated to clinical research innovations. Buyer Authority: Attendees include clinical research professionals from pharma, biotech, and regulatory sectors. SCOPE Summit is crucial for advancing clinical research,.

Attendees, exhibitors & solutions

Who this event is for

Visitor profile

Typical attendee groups you can expect to meet.

Clinical operations professionals from pharma and biotech companies

Regulatory affairs specialists

Research site coordinators and managers

Clinical trial technology providers

Patient advocacy representatives

Investors in clinical research innovations

Exhibitor profile

Main supplier and exhibitor segments present at the show.

Pharmaceutical companies showcasing new drugs and therapies

Biotechnology firms focusing on innovative clinical solutions

Clinical research organizations (CROs) offering trial management services

Technology providers for clinical trial data management

Patient engagement solution providers

Regulatory consulting firms

Product categories

Key solution areas showcased across the event.

Clinical trial management software and solutions

Patient recruitment and engagement tools

Data analytics platforms for clinical research

Regulatory compliance solutions

Biomarker and biospecimen management technologies

Supply chain solutions for clinical trials

Location & Facilities

Venue

Open in Google Maps

Rosen Shingle Creek

Orlando, USA

Attend

Entry & tickets

Event days & opening times

DayOpening hours

1 March –9:00 AM – 5:00 PM

2 March –9:00 AM – 5:00 PM

3 March –9:00 AM – 5:00 PM

4 March –9:00 AM – 5:00 PM

Early Bird
Register by October 2, 2026, to save up to $1,100.
$1,100.00

Who runs the show

Organisers

Cambridge Healthtech Institute

Director, Sales

Email Call Website

What's on

Programme

Conference Track

Event days

01:00 PM–12:30 PM

Typical time

Official agenda

This agenda is still being finalised. Check the official agenda for the latest sessions.

Monday, Mar 1, 2027

01:00 PM – 02:00 PM

Technology, Data, and AI/ML for Intelligent Trial Design

Conference Track

09:00 AM – 10:00 AM

Data-Driven Feasibility and Investigator Selection

Conference Track

10:15 AM – 11:15 AM

Patient and Site Voice in Protocol Design

Conference Track

11:30 AM – 12:30 PM

Tech and Collaboration to Streamline Start-Up and Reduce Site Burden

Conference Track

Tuesday, Mar 2, 2027

01:00 PM – 02:00 PM

Clinical Trial Budgeting, Contracting, and Payments

Conference Track

09:00 AM – 10:00 AM

Modernizing Lab, Biospecimen & Data Management Operations

Conference Track

10:15 AM – 11:15 AM

Communication & Digitization for End-to-End Clinical Supply Management

Conference Track

Wednesday, Mar 3, 2027

01:00 PM – 02:00 PM

Building Strategic Sponsor-Site Partnerships

Conference Track

09:00 AM – 10:00 AM

Enrollment Strategy and Trial Readiness

Conference Track

10:15 AM – 11:15 AM

Access, Trust, and Participant Engagement

Conference Track

How the last edition performed

Previous edition

Current edition

2027 · 5,000 visitors · 325 exhibitors

Forecast — not final

Visitors

4,500

Impact

A bigger and stronger platform

Visitor total from organiser recap language in captured sources. The most recent edition recorded 4,500+ visitors. SCOPE Summit 2027, taking place from March 1-4 at Rosen Shingle Creek in Orlando, Florida, is the 18th annual gathering of the clinical research community. The event features 38 conference tracks and over 325 exhibitors, focusing on innovations in clinical trials. SCOPE Summit is crucial for advancing clinical research, providing a platform for professionals to share.

Audience quality

High-value decision-makers

Visitors typically include Clinical operations professionals from pharma and biotech companies, Regulatory affairs specialists, Research site coordinators and managers, Clinical trial technology providers. Dates and Venue: SCOPE Summit 2027 runs March 1-4, 2027, at Rosen Shingle Creek, Orlando, Florida. Scale and Focus: The event features over 325 exhibitors and 38 conference tracks dedicated to clinical research innovations. Organiser: Hosted by Cambridge Healthtech Institute, more information can be found at.

Exhibitor outcomes

Real business growth

Intelligence

Market context

Key market insights, trends, news and related events to help you understand the bigger picture.

North America — Orlando, Florida, USA (US Southeast)

Why it matters

Attending Summit for Clinical Ops Executives SCOPE on 2027-03-01 to 2027-03-04 in Orlando lets buyers and specifiers benchmark suppliers, see live demonstrations, and compress months of vendor meetings into one focused trade visit — worthwhile when your category roadmap aligns with the official exhibitor profile.

Industry trends

Key trends shaping this market and its wider industry.

Digital buyer journeys

Pre-scheduled agendas, product finders and meeting tools now shape how clinical operations buyers plan and compare vendors before they travel.

Sustainability in procurement

Energy use, recyclable materials and carbon reporting are moving into sponsor and CRO procurement requirements as ESG criteria reach trial vendor selection.

Automation and labour efficiency

Clinical operations teams are benchmarking automation, eClinical software and outsourced services that cut manual effort and total cost per trial.

Regional supply-chain resilience

Sponsors and CROs are diversifying trial vendors and sites across regions while favouring partners that offer local service, training and support.

Hybrid engagement models

Live on-site demonstrations remain decisive, but post-show webinars, digital catalogues and supplier portals extend the commercial window beyond the event.

Clinical operations and trial technology circuit

Lock Orlando hotels and partnering meetings 8–12 weeks before the early-March window; the peer clinical research calendar clusters between February and October.

Clinical operations, clinical data and outsourcing leaders plan SCOPE Summit alongside peer clinical research meetings to benchmark CRO partners, eClinical platforms, site networks and supply-chain vendors across the year.

Pre-show

Confirm CRO, eClinical and site-network meetings through the partnering platform and pre-book I-Drive hotels before spring-break pricing lifts rates.

Show week

Session tracks by morning, exhibit and partnering hall by afternoon, receptions and client dinners along International Drive in the evening.

Peer events are established clinical research and trial technology meetings; verify dates and venues on each organiser website before booking.

Plan your trip

Travel & logistics

Local currency · USD

Arrival airports

Choose from the following airports, with convenient access to the event and venue.

MCO

Orlando International Airport

Primary gateway for SCOPE, with nonstop service from most US hubs plus London, Toronto and Latin America. Take FL-528 (Beachline) West to Universal Blvd; rideshare pickup is on Level 2 of Terminals A and B.

~19 km (12 miles)

to venue

20–30 min off-peak; allow 40–45 min between 5 and 7 PM

by car

SFB

Orlando Sanford International Airport

Secondary gateway used mainly by European and Canadian leisure carriers. Fewer daily frequencies and higher transfer cost, so compare total trip price against MCO before booking.

~56 km (35 miles)

to venue

45–55 min via FL-417 toll road

by car

Hotel tiers

A range of accommodation options near the venue and across key areas.

tier

On-site at the SCOPE venue, 9939 Universal Blvd

Not yet confirmed

1,500-room resort with the conference centre under the same roof — no commuting, and the fastest access to early sessions and evening receptions.

source

tier

International Drive, ~4 km from the venue

Not yet confirmed

Full-service convention hotel attached to the Orange County Convention Center; strong for sponsor teams hosting client dinners.

source

tier

Destination Parkway, ~2.5 km from the venue

Not yet confirmed

Closest large full-service alternative to the resort, with resort-style pool deck and quick rideshare access to Rosen Shingle Creek.

source

tier

International Drive, ~3 km from the venue

Not yet confirmed

Mid-range sister property of the venue hotel; frequent SCOPE attendees use it to cut nightly cost while staying in the same I-Drive cluster.

source

tier

International Drive, ~3.2 km from the venue

Not yet confirmed

Reliable mid-range option within a 10-minute rideshare of the conference centre, close to I-Drive restaurants and the I-Ride Trolley line.

source

tier

SeaWorld / south International Drive, ~2.6 km from the venue

Not yet confirmed

Budget tier with breakfast included; best value for attendees travelling on a self-funded or academic budget.

source

Local transport

Get around the city with these convenient transport options.

rideshare

Estimated costUSD 30–45 for UberX or Lyft; surge can reach USD 60+

Best forOrlando International (MCO) to Rosen Shingle Creek

Pickup is on Level 2 of MCO Terminals A and B at the marked rideshare curb. The run takes 20–30 minutes off-peak via FL-528 and Universal Blvd.

taxi

Estimated costUSD 50–70 metered, plus tolls

Best forOrlando International (MCO) to Rosen Shingle Creek

Metered taxis rank outside both MCO terminals and charge a USD 2–3 airport departure fee; useful when arriving after midnight with luggage.

bus

Estimated costUSD 25–35 one way per person

Best forMears shared shuttle to International Drive hotels

Booked desks in the MCO baggage claim areas; the shared shuttle stops at I-Drive hotels and drops within a short walk or rideshare of the resort entrance.

bus

Estimated costUSD 2.00 per ride; USD 4.50 all-day pass

Best forLYNX Route 42 along International Drive and Universal Blvd

LYNX links the I-Drive corridor with MCO via Routes 11 and 111. No stop at the resort gate — allow a 10–15 minute walk or a short rideshare from Universal Blvd.

bus

Estimated costUSD 2.00 per ride; USD 6.00 unlimited day pass

Best forI-Ride Trolley along International Drive (SeaWorld to Premium Outlets)

Runs every 15–20 minutes from about 8 AM to 10:30 PM and stops at most I-Drive hotels, making it the cheapest way to move between hotels and restaurants during the week.

train

Estimated costUSD 39–99 one way depending on fare class

Best forOrlando International Airport (MCO) to Rosen Shingle Creek

Brightline serves MCO's Intermodal Terminal for onward trips to South Florida; it is not a local transfer to the venue, but it makes a Miami pre- or post-show extension easy.

taxi

Estimated costUSD 35–75 taxi or rideshare to the venue district

Best forOrlando Sanford International Airport (SFB) to Rosen Shingle Creek

45–55 min via FL-417 toll road; Secondary gateway used mainly by European and Canadian leisure carriers. Fewer daily frequencies and higher transfer cost, so compare total trip price against MCO before booking.

Plan your trip

Visa & entry documents

Check the latest visa requirements and entry guidelines before travelling.

Visa required

ATA Carnet: accepted

Canadian citizens generally enter visa-free for business visits with proof of purpose; Mexican nationals with a valid B-1/B-2 or border crossing card may travel for business meetings.

US Customs and Border Protection accepts ATA Carnets for temporary admission of professional and exhibition equipment, so list demo hardware, monitors and laptops before shipping to the Rosen Shingle Creek freight dock.

Official visa page

Weather

Orlando in early March is warm and mostly dry, with daytime highs of 24–27 °C (75–81 °F) and overnight lows of 13–16 °C (55–61 °F) — evenings on the Rosen Shingle Creek grounds feel cool after air-conditioned session rooms. Expect roughly 75–90 mm of rain spread across 7–8 days of the month, usually as short afternoon showers rather than all-day rain. Pack light layers, a compact umbrella, comfortable walking shoes for the sprawling conference centre, and sunscreen for the outdoor networking terraces; March also opens Florida's tree-pollen season, so bring antihistamines if you are sensitive.

Plan for the climate

Check temperatures and pack accordingly

Venue connectivity

AT&T, T-Mobile and Verizon all deliver strong 5G coverage across Orlando, International Drive and the Rosen Shingle Creek resort, and the venue provides guest Wi-Fi in sleeping rooms and meeting space. International visitors should buy a prepaid eSIM before departure — T-Mobile, Verizon and Airalo or US Mobile tourist plans generally run USD 10–40 for a week of data — or activate a roaming pass with their home carrier. US networks use GSM/LTE/5G bands, so modern unlocked handsets work without issue; shared convention Wi-Fi can slow during peak keynote times, so a phone hotspot is a useful backup for live demos and video calls.

Ride-hailing

Taxis

Public transit

Car rentals

Cultural notes

Useful information to help you have a smooth and respectful visit.

Tipping

US service staff rely on tips: 18–20% on restaurant bills, USD 2–5 per bag for hotel porters, USD 1–2 per drink at the bar, and an optional 15–20% for rideshare and taxi rides prompted in-app.

Business dress and meetings

Clinical operations and pharma attendees dress business casual — collared shirts, chinos or trousers, light jackets, no tie required. Expect first names immediately, a firm handshake and punctual starts; the agenda keeps sessions to 60 minutes with tight 15-minute changeovers.

Conversation norms

US colleagues open with brief small talk then move quickly to the commercial point. Sponsor and CRO discussions are direct about pricing, timelines and references, so come prepared with concrete data on enrolment performance and site metrics.

Practical guides

Visitor & Exhibitor Essentials

Everything needed to arrive prepared, navigate the event, and make the visit productive.

Flights

Destination: MCO

Book into MCO for the shortest transfer to Rosen Shingle Creek; SFB makes sense only when fares are materially lower, and Tampa (TPA) adds a 1h30m drive. Early March is peak Orlando season around spring break, so book 8–12 weeks out — Google Flights price history for New York–Orlando shows the cheapest window is roughly mid-November to mid-February, with sample round-trips from about USD 182. Nonstop services from London, Toronto and major US hubs fill fastest for the Sunday 28 February / Monday 1 March arrivals, so lock those first. Exhibitors and anyone shipping booth materials should add a buffer day for freight and setup at the venue.

Visa

Most international attendees need either an approved ESTA (Visa Waiver Program, USD 21, valid two years) or a US B-1 business visitor visa (USD 185 MRV fee with a consular interview). Apply for ESTA at least 72 hours before departure and start a B-1 application three to four months ahead, as interview slots at many consulates are limited. Carry your SCOPE registration confirmation, hotel reservation and a Cambridge Healthtech Institute invitation letter when you travel, since US Customs officers may ask for proof of the purpose and length of your visit.

Estimated cost: Varies by visa type and nationality (check official site).

Processing: Varies by nationality; apply several weeks before travel.

Apply only at esta.cbp.dhs.gov; the ESTA is valid for two years and requires a biometric e-passport. Carry your SCOPE registration confirmation, hotel booking and a Cambridge Healthtech Institute invitation letter to the consular interview.

Official

Hotels

Find a stay near the venue with options for every budget.

Check-in (recommended)

2027-03-01

Check-out (recommended)

2027-03-04

Areas to stay

Destination Parkway, ~2.5 km from the venue · International Drive, ~3 km from the venue · International Drive, ~3.2 km from the venue · International Drive, ~4 km from the venue · On-site at the SCOPE venue, 9939 Universal Blvd

mid range

USD 260-420/night

Book

mid range

USD 240-400/night

Book

mid range

USD 220-360/night

Book

mid range

USD 170-260/night

Book

mid range

USD 160-240/night

Book

mid range

USD 130-200/night

Book

Transport

Get to the venue and around the city with these options.

Airport → venue: Primary gateways: Orlando International Airport (MCO): 20–30 min off-peak; allow 40–45 min between 5 and 7 PM; Orlando Sanford International Airport (SFB): 45–55 min via FL-417 toll road. Allow road or rail time to Rosen Shingle Creek; on-site parking is usually available at major exhibition venues.

Hotel → venue: Precinct hotels near Rosen Shingle Creek: On-site at the SCOPE venue, 9939 Universal Blvd: Rosen Shingle Creek; International Drive, ~4 km from the venue: Hyatt Regency Orlando; Destination Parkway, ~2.5 km from the venue: Hilton Orlando.

Ride-hail: Uber and Lyft operate throughout Orlando, with dedicated pickup zones on Level 2 of MCO Terminals A and B and a signed rideshare loop at Rosen Shingle Creek's main entrance. An UberX from MCO to the resort typically runs USD 30–45 and takes 20–30 minutes off-peak, rising to USD 60 or more during conference peaks and evening thunderstorms. From International Drive hotels the trip is usually USD 10–18, and drivers queue reliably after the evening SCOPE receptions.

Public transit: LYNX, Orange County's bus network, runs Route 42 along International Drive and Universal Blvd and connects to MCO via Routes 11 and 111, at USD 2.00 per ride or USD 4.50 for an all-day pass. The I-Ride Trolley covers the heart of International Drive between SeaWorld and the Premium Outlets every 15–20 minutes from roughly 8 AM to 10:30 PM for USD 2.00 per ride or USD 6.00 for an unlimited day pass. Neither service stops at the resort gate, so plan a 10–15 minute walk or a short rideshare from the nearest Universal Blvd stop. SunRail commuter rail serves downtown Orlando and Kissimmee but does not reach the International Drive resort cluster.

Parking: Rosen Shingle Creek provides self-parking and valet for overnight guests and conference day visitors, with self-parking typically in the USD 22–28 per night range and valet around USD 35–40. Day visitors attending SCOPE sessions pay a reduced posted day rate at the gate; the resort also runs shuttles to selected I-Drive attractions. If you stay off-property, most International Drive hotels include free self-parking, but parking at the conference centre itself is chargeable and fills early on keynote mornings.

Weather

Plan and pack for the event climate.

Month: March 2027 (Orlando, Florida)

Temperature: Daytime 24–27 °C (75–81 °F); overnight 13–16 °C (55–61 °F)

Seasonality: Late dry season with moderate rain — roughly 75–90 mm spread over 7–8 days of the month, usually short afternoon showers. March also starts Florida's pollen season and the run-up to spring-break humidity.

Packing: March 2027

Plan your trip

Planning

Best day to visit: Monday 1 March 2027

Monday 1 March carries the highest session density in the published programme, with four conference-track blocks spanning data-driven feasibility and investigator selection, patient and site voice in protocol design, start-up technology, and AI/ML trial design — the widest single-day view of the clinical operations agenda. Arriving on Sunday 28 February lets you collect badges early and fill your partnering diary before the hall opens. If outsourcing and budgeting are your priority instead, Tuesday 2 March concentrates lab and biospecimen operations, clinical supply digitisation and trial budgeting and payments in one day.

Check passport validity and US entry status — Confirm your passport is valid for at least six months beyond travel and verify ESTA or B1/B2 visitor visa requirements; start any visa paperwork immediately.

Register for SCOPE online — Complete visitor registration via the official scopesummit.com site and save the confirmation for badge collection at Rosen Shingle Creek.

Book flights to Orlando — Target Orlando International (MCO) for the shortest transfer; compare Orlando Sanford (SFB) only if fares are materially lower for the 1-4 March 2027 dates.

Reserve a hotel near the venue — Secure a room along the International Drive corridor within about 3-5 km of Rosen Shingle Creek; early March Orlando demand is high.

Build your session agenda — Shortlist clinical operations tracks covering trial execution, clinical data, outsourcing and site engagement on the SCOPE programme.

Request networking meetings — Reach out to sponsors, CROs and technology vendors to pre-schedule one-to-one meetings before the show floor opens.

Arrange airport transfer — Book a taxi, rideshare or rental car from MCO; note drive time to the venue and confirm on-site parking at the resort.

Download venue map and programme — Save the venue map, conference app and session schedule once the organiser publishes them to plan daily routes.

Check Orlando weather — Early March in Orlando is typically warm by day with cooler evenings; pack layers and a light jacket.

Prepare meeting materials — Bring business cards, a one-page capability summary and any case studies relevant to clinical operations partnerships.

Pre-book workshops — Register for any executive briefings, workshops or ancillary sessions that require a separate ticket.

Confirm travel documents and Day-1 plan — Save all reservations, plan arrival for badge pickup and allow buffer time for registration queues on day one.

Sample visitor itinerary

Route-optimised day

15:00–20:00

Arrival, hotel check-in at Rosen Shingle Creek and on-site badge collection, followed by an informal drinks round in the lobby lounge to pre-book partnering meetings.

08:00–12:30

Opening day conference tracks: 'Data-Driven Feasibility and Investigator Selection' (09:00), 'Patient and Site Voice in Protocol Design' (10:15) and 'Tech and Collaboration to Streamline Start-Up and Reduce Site Burden' (11:30).

13:00–18:00

'Technology, Data, and AI/ML for Intelligent Trial Design' (13:00), then the exhibit and partnering hall for eClinical, eSource and CRO demonstrations, closing with the evening networking reception.

09:00–17:00

'Modernizing Lab, Biospecimen & Data Management Operations' and 'Communication & Digitization for End-to-End Clinical Supply Management' on Tuesday, 'Clinical Trial Budgeting, Contracting, and Payments' in the Tuesday afternoon, then 'Enrollment Strategy and Trial Readiness' on Wednesday morning before departure on Thursday 4 March.

Side trips

Kennedy Space Center Visitor Complex, Merritt Island

Winter Park and downtown Orlando

Networking spots

SCOPE Partnering & Exhibit Hall, Rosen Shingle Creek convention centre

Structured B2B Partnering Zone

One-to-one meetings with CROs, eClinical and eSource vendors, site networks and lab services are booked through the partnering platform; tables turn over fast, so schedule slots before you travel.

Headwaters Lounge and resort lobby, Rosen Shingle Creek

Informal Evening Networking

The natural after-session spot where clinical operations leads and sponsor teams continue conversations; seats fill quickly once the closing sessions end around 17:30.

Pointe Orlando and ICON Park, International Drive

Off-Site Client Dinners

A 5 km, 10-minute rideshare from the venue with a dense cluster of restaurants that take group bookings — the standard choice for sponsor–CRO dinners and site-network hospitality.

Budget

Costs & budget

Build your working budget

Adjust the inputs below to create a directional event budget.

Number of nights

Estimated budget

Live estimate

Per diem × 2$150.00
Visa$21.00

Estimated total$171.00

This is a directional estimate. Please verify live rates before booking.

Cost reference

Official cost items and estimated ranges for exhibitors.

visitor_ticket

visitor · Early Bird

USD 1100 / per person

official

visa_fee

visitor · Entry visa

USD 21 / per application

official

Item	For	Tier	Estimated range	Status	As of
visitor_ticket	visitor	Early Bird	USD 1100 / per person	official
visa_fee	visitor	Entry visa	USD 21 / per application	official

Decision

Visit, exhibit, or skip?

Should you go?

Pick the closest answer for each. Your recommendation updates live.

QUESTION 1 OF 6

What is your primary role?

Decision matrix

Compare participation options side by side to choose the best fit for your objectives.

visit

Assess how this option fits your objectives.

Best for

Clinical operations, clinical data and outsourcing decision-makers who want to evaluate CROs, eClinical and trial technology vendors in one place.

Min. budget

$1,400.00

Timeline

4-6 weeks for flights and a hotel near Rosen Shingle Creek; longer if a US visa or ESTA is required.

Risks

Early March Orlando conference pricing peak

US visa or ESTA lead time for international attendees

exhibit

Assess how this option fits your objectives.

Best for

CROs, eClinical and eSource providers, clinical technology and site services suppliers targeting sponsor and pharma clinical operations buyers.

Min. budget

$6,300.00

Timeline

3-4 months for stand booking, design, build and freight to Orlando.

Risks

Hall and stand allocation on a first-come basis

Freight and customs lead time for demo equipment

skip

Assess how this option fits your objectives.

Best for

Teams with no clinical operations, clinical data or trial outsourcing remit in the 2027 planning cycle.

Min. budget

Not yet confirmed

Timeline

Not applicable.

Risks

Missing early networking and pre-show meeting scheduling

Book with

Partners

Recommended providers

Visa

US Department of State

Gallery

Photos

Official imagery from Summit for Clinical Ops Executives SCOPE

Official Summit for Clinical Ops Executives SCOPE event branding

FAQs & glossary

Answers

Glossary

CRO: Contract Research Organisation - a company that sponsors and biopharma firms outsource clinical trial execution to, covering site management, monitoring and data services.
EDC: Electronic Data Capture - software used to collect, clean and manage clinical trial data entered by study sites.
eSource: Direct capture of trial data in electronic form at the point of care, replacing paper source documents at the site.
GCP: Good Clinical Practice - the international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials.
IRB / IEC: Institutional Review Board or Independent Ethics Committee - the body that reviews and approves a trial protocol and protects participant rights before enrolment.
IND: Investigational New Drug application - the regulatory filing submitted to the US FDA before an investigational therapy can be tested in humans.
SIV: Site Initiation Visit - the meeting where a study site team is trained and activated to begin screening and enrolling participants.
RBM: Risk-Based Monitoring - a clinical oversight approach that concentrates monitoring effort on the highest-risk data, sites and processes.
PI: Principal Investigator - the lead physician responsible for conducting the trial and clinical decisions at a study site.
CDISC: Clinical Data Interchange Standards Consortium - the body that sets data standards for organising and submitting clinical trial data to regulators.

Trust footer

Sources

References

Publishers

Date checked

SCOPE Summit

Official Website
Lang: EN
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SCOPE Summit LinkedIn
Lang: EN
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SCOPE Summit Twitter
Lang: EN
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