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Clinical Drug Development

Proven Results

Your success depends on your ability to move from early research through clinical trials and regulatory review to the market in the shortest time. Genuine Pharma has helped many clients find success, therefore, it is not surprising that nearly 80% of our business is from repeat customers.

Services Tailored For You

Services that matter are the ones that can speed your product through to the market. Genuine Pharma possesses the expertise and tools to help you plan and navigate the shortest possible route to market.

Clinical Trials: Phase I - IV

From “First Man in” and “Proof of Concept” to Phase IV post-marketing studies, and everything in between, we offer a broad range of facilities and therapeutic expertise to meet the clinical trial needs. Let us manage the complete clinical trial process, including planning, patient and investigator recruitment, data management, biostatistics, clinical pharmacology, and regulatory compliance.

Clinical Trial examples …

  • Assessment of efficacy and safety of loxoprofen sodium versus diclofenac sodium in low back pain (SAJA CS–600/SA/301), Double blind Randomized Controlled Clinical Trial

  • Assessing the impact of adding SF-1008C (Aminoleban EN) to the therapy of patients with chronic hepatic disease in improving their quality of life (OTSUKA SF–1 008C/ET/401)

  • Multicenter Phase IV Study of TO-70 a New Amino Acid Injection for Acute and Chronic Renal Failure Patients with Hypoproteinemia or Hypoalbuminemia (OTSUKA TO – 70 / ET / 401)

To better assist our clients with pre-launch activities, these studies enjoyed the consistency provided by Genuine Pharma that has been a key factor in their success. This consistency is achieved through ...

  • A Core Team: Project Manager, CRA and Data Manager, who are experienced in clinical trials

  • A CRA pool for monitoring activities

  • A Call Center to serve the communication needs of investigators, track regulatory documents and maintain the central file to guarantee ICH-GCP compliance

  • A Logistics Center responsible for providing study supplies as needed

  • Proactive management of study sites and efficient monitoring visits planning

  • Use of document templates, project status metrics, and overall project progress

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Biostatistics

Delivering what you need

Biostatistics is key to clinical trials, and needs to be handled with expertise and attention to detail. We take time to understand your specific requirements and provide an exceptional service with high quality deliverables within impressive timelines

Integral Part or Standalone?

Whether you require our services as an integral part of a full clinical program, or as a standalone consulting, biostatisticians, and biostatistical programmers can quickly step in to make significant contributions to your ongoing work.

Analysis Services

  • All design, analysis and reporting is based on ICH guidelines, client needs, and our own extensive procedures

  • Rigorous QC methods are employed at all stages

  • Statistical aspects of study design

    • Design alternatives

    • Input into protocol

    • Sample size calculations

    • Randomization

    • CRF design review

  • Statistical analysis planning

    • Methodology development and evaluation

    • Analysis plan

  • Data analysis

    • Blind review of protocol violations

    • Classification of patients into analysis sets

    • Independent QC through double programming and peer review

  • Reporting

    • Presentation formatting

    • Statistical reporting

    • Integrated clinical and statistical reports

    • Development, documentation and reporting

    • Interface with regulatory authorities

  • Quality control services

    • QC of client analysis and reports

    • Independent reprogramming and review

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Clinical Pharmacology

We understand the tremendous pressure placed on today's pharmaceutical firms to shorten the drug development cycle, yet maintain research and product quality.

The race to develop new compounds and bring them to market as quickly as possible hinges on the success of early conducted trials

To meet this need, we have carefully developed a network of clinical pharmacology research units and bioanalytical laboratories with highly trained staff

Selected benefits of this Network include:

  • Parallel drug development in multiple units, from First in Man to Proof of Concept (Phase I, II studies)

  • Synergy among research units, knowledge transfer

  • Coordinated network from one management team

  • Uniform high quality

  • Meeting regulatory requirements

  • Reduced time-to-market for promising new compounds

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Contract Personnel

A shortage of skilled clinical professionals is sometimes all that stands between success and failure

Why Use Genuine Pharma's contract personnel Professionals?

  • Capable — knowledgeable in a wide range of therapeutic areas

  • Experienced — self-motivated with extensive industry experience

  • Flexible — skilled staff available on short notice for assignments lasting from several days to several months

  • Cost Effective — optimize your budget and management resources

  • Efficient — keep projects on track and reduce the time you would spend on training new employees

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Consulting

With more than 10 years industry experience, our consultants offer knowledgeable advice ranging from a single trial design to complete product development programs, for example ...

  • Protocol development and review

  • Sample size calculations

  • Statistical help desk (immediate statistical consulting)

  • Data Monitoring Committees (DMCs) and Data Safety Monitoring Boards (DSMBs)

  • Statistical methods for detection / evaluation of fraud

  • Meta analysis

  • Support and review of publications

  • Conference presentations

  • Marketing support

  • Representation of clients at regulatory agency meetings

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Data Management

Our in-depth understanding of the entire drug development process allows us to design the right blend of data management, programming, and project management resources

Proper handling of clinical data is essential to the success of your trials and the ability to win regulatory approval and market acceptance

We provide centralized data management coordination and local support for studies of any size, including multinational efforts

Data Management Services include

  • Case Report Form Design

  • Database Design

  • Secondary Data Review

  • Medical Data Coding (Drug-88, ICD9, etc.)

  • Incorporation and cleaning of other electronic data (lab, ECG, etc.)

  • Computerized edit checks

  • CRF tracking and audit trail documentation

  • Data Entry and verification

  • Database validation and auditing

  • Serious Adverse Event Reconciliation

  • Adverse Event/Medication Coding

Due to our extensive expertise we were entrusted with the conduct and data management of Egypt’s participation in the WHO/Health Action International Medicine Prices International Survey Project

The project was delegated to us by the Central Administration of Pharmaceutical Affairs (MOHP) and the regional WHO office in Egypt

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Medical Services

Medical Services can provide strategic guidance in drug development. These include:

  • Medical consultation

  • Project team leadership

  • Safety services

  • Pharmacovigilance

  • Therapeutic area training

  • Data safety monitoring boards (DSMBs)

  • SAE reporting and document preparation

Our medical advisors can:

  • Serve as your expert representatives

  • Serve as your liaison with regulatory agencies

  • Provide scientific guidance

  • Help tailor marketing presentations

  • Provide MD to MD contact

Our medical consultants can

  • Interact with investigator sites for the management of SAEs

  • Provide protocol clarifications

  • Help with randomization

  • Liaison with medical monitors

  • Code SAEs and conduct safety trend analysis

Due to our recognized experience we were asked by the MOHP/ WHO collaborative effort to provide technical consultation for 3 national-scale projects:

  • The National Drug Policy (2nd edition)

  • The Egyptian National Formulary

  • Guidelines of implementing Drug Management

Our continued support for MOHP/WHO projects is currently extending to:

  • Development of training modules for implementing the Guidelines for Drug Management

  • The National Essential Drug List

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Reporting / Medical Editing

Genuine Pharma's medical editors can formatt the output reports of clinical trials according to the guidelines of all major medical publications

The service of manuscript preparation for publishing purposes is also available to those seeking medical editing of their own content

Advertorials are among our medical editing jobs and we usually publish in the British Medical Journal (BMJ), middle east edition, and Modern Medicines, middle east edition.

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Regulatory Affairs

With our DRA department headed by a former undersecretary of state for MOHP, our DRA staff know the local regulatory landscape and have established regulatory contacts

Regulatory Strategy Consulting: Our regulatory consultants can help reduce your time-to-market by designing practical regulatory plans, or by reviewing your own plans and recommending specific actions and choices that can save time and resources

Clinical Quality Assurance: The dramatic increase in clinical trial activity calls for ever-increasing emphasis on compliance with Good Clinical Practices (GCP)

Our experienced Clinical QA professionals will conduct in-depth audits of your sites and your documents/reports to ensure that they are GCP-compliant. We provide the approach required to ensure compliance with ICH/GCP consolidated guidelines.

Due to our extensive experience in the DRA arena we were entrusted by multinational companies to proceed with their DRA activities in Egypt e.g. Swedish Orphan International, A.B., (Sweden) and Apotex Inc., (Canada), SAJA Pharmaceuticals (Japan/KSA)

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