Protocol Development
The protocol defines the quality of everything that follows. Our medical, regulatory and statistical experts develop the protocol and every essential study document, so your study secures approval with confidence and performs reliably at every site.
Most challenges encountered during a clinical study originate in its protocol: an endpoint that is difficult to measure, eligibility criteria that limit recruitment, a visit schedule participants struggle to follow, or a supply plan that stalls at importation. Our experience across studies in Egypt allows us to anticipate these weaknesses and resolve them at the design stage.
At Insight, protocol development is a multidisciplinary undertaking. Physicians, regulatory specialists, clinical operations managers, data managers and biostatisticians work together to translate your research question into a coherent, submission-ready package: the protocol, informed consent, case report forms, statistical analysis plan and the operational plans that support them.
Whether you require a complete protocol from concept, the adaptation of a global protocol to Egyptian requirements, or an independent expert review of an existing draft, you work with a single team that understands both the science and the realities of study conduct.
The complete documentation framework for your study
A protocol is never submitted alone. We prepare the full suite of scientific, regulatory and operational documents that ethics committees, the authority and investigators expect to review.
Clinical trial protocol
A comprehensive protocol aligned with ICH E6 (R3) and the ICH M11 structure, covering rationale, objectives and endpoints, design, population, interventions, assessments, safety reporting, statistics and ethical considerations.
Protocol synopsis
A concise outline of the study for early feasibility, investigator engagement and internal governance, so that pivotal design decisions are agreed before the full protocol is drafted.
Informed consent documents
Participant information sheets and consent forms in Arabic and English, together with assent forms for minors and versions for legally acceptable representatives where required.
Case report forms (CRFs)
Electronic case report forms on Insight EDC, designed with our data management team to capture precisely what the protocol requires, in a format investigators can complete accurately.
Investigator’s brochure
Preparation or revision of the investigator’s brochure, presenting the clinical and non-clinical evidence investigators need to evaluate the anticipated risks and benefits.
Statistical analysis plan
Sample size justification, analysis populations, methods for primary and secondary endpoints, handling of missing data and planned interim analyses, prepared by our biostatisticians.
Participant-facing materials
Patient diaries, questionnaires, identification cards, recruitment notices and visit reminders, written in accessible language and submitted for ethics approval.
Study plans and manuals
Monitoring, data management and safety management plans, together with laboratory and pharmacy manuals, ensuring every function operates from consistent instructions.
Protocol amendments
Well-justified amendments when the study must evolve, accompanied by a summary of changes and revised consent documents ready for resubmission.
From research question to an approved, executable study
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Medical and scientific evaluation
Our physicians assess the investigational product, the therapeutic area and the existing evidence, refining the research question, the hypothesis and the study’s position within your development strategy.
- 02
Study design
We define the design best suited to your objectives: randomisation, blinding, comparators, treatment duration, visit schedule, and primary and secondary endpoints of clear regulatory and clinical relevance.
- 03
Population and eligibility
Inclusion and exclusion criteria are crafted to safeguard participants while remaining achievable, and are validated against the patient populations actually treated at hospitals in Egypt and the region.
- 04
Regulatory obligations
We map the requirements of the Egyptian Drug Authority, the Supreme Council for Clinical Research Ethics and Law No. 214 of 2020, and of other authorities in multinational studies, and embed them in the protocol from the outset.
- 05
Site-specific requirements
We verify what each site needs to deliver the study, including equipment, laboratory and imaging capabilities, staffing, storage, local procedures and institutional review, and adapt the protocol wherever execution would otherwise be compromised.
- 06
Logistics and supply
Investigational product packaging, labelling, importation, storage and temperature control, sample collection and shipment, and central laboratory arrangements are planned in parallel with the protocol.
- 07
Safety planning
Adverse event definitions, reporting timelines, stopping rules and the remit of any data monitoring committee are defined precisely, in line with ICH E2A and local requirements.
- 08
Statistics and analysis plan
Our biostatisticians determine the sample size, define the analysis populations and prepare the statistical analysis plan, ensuring the study is adequately powered to deliver a conclusive answer.
- 09
Data collection design
CRFs and data flows on Insight EDC are derived directly from the schedule of assessments, so that every data point serves a defined purpose and duplication is avoided.
- 10
Informed consent and participant materials
Consent documents and participant materials are drafted in clear Arabic and English, reconciled with the protocol, and aligned with each ethics committee’s template.
- 11
Review and finalisation
Principal investigators, your team and our medical, regulatory and data specialists review each draft. We consolidate their input and finalise a version-controlled protocol package.
- 12
Submission readiness
The final package is compiled for ethics committee and authority submission, and we address every enquiry on the design through to approval.
Protocols authored by the team that delivers them
Our own project managers, monitors and data managers conduct the studies we design, so every protocol is written with a precise understanding of conditions at the sites.
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Fewer amendments
Achievable eligibility criteria and practical visit schedules reduce costly modifications once the study is under way.
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Efficient approvals
Documents that anticipate the expectations of ethics committees and the authority progress through review with fewer queries.
- 03
Reliable evidence
Endpoints, CRFs and the analysis plan are designed as one, so the data collected answers the question posed.
- 04
Participant protection
Rigorous safety provisions and clear consent documents keep participant wellbeing at the centre of the study.
Grounded in international and Egyptian requirements
- 01
ICH E6 (R3) and ICH M11
Good Clinical Practice and the harmonised structure for clinical protocols.
- 02
ICH E8 (R1) and ICH E9
General considerations for clinical studies and statistical principles for clinical trials.
- 03
SPIRIT 2013
The recognised checklist of items for a complete clinical trial protocol.
- 04
Law No. 214 of 2020 and EDA requirements
Egypt’s legislation on medical research and the Egyptian Drug Authority’s clinical trial guidance.
- 05
Declaration of Helsinki and CIOMS
The international ethical principles governing research involving human participants.
More from our clinical research team
Clinical Studies Management
Our flagship full-service offering, from feasibility to the final clinical study report.
Site Selection and Management
Rigorously selected investigators and sites, supported from feasibility to close-out.
Clinical Monitoring
Risk-based monitoring to local and global multinational standards.
Data Management and Biostatistics
Validated data on Insight EDC and statistical analysis that withstands scrutiny.
Medical Writing
Clinical, regulatory and publication documents of the highest scientific standard.