CLINICAL DEVELOPMENT

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CLINICAL DEVELOPMENT

For more than 6 years Megalek has been providing clinical development services to the pharmaceutical and medical device industries. Working closely with our clients, we overcome challenges and optimise solutions for the common goal of achieving superior trial outcomes. As part of the strategic partnership we offer optimization of your clinical trials and accelerating the delivery of your innovative products to the physicians and patients who need them.

CLINICAL DEVELOPMENT SOLUTIONS OVERVIEW

CLINICAL DEVELOPMENT

For more than 6 years Megalek has been providing clinical development services to the pharmaceutical and medical device industries. Working closely with our clients, we overcome challenges and optimise solutions for the common goal of achieving superior trial outcomes. As part of the strategic partnership we offer optimization of your clinical trials and accelerating the delivery of your innovative products to the physicians and patients who need them.

CLINICAL DEVELOPMENT SOLUTIONS OVERVIEW

CLINICAL TRIAL PHASES:

Phase II
Phase III
Phase IV
Registries
Medical devices
Orphan indications

CLINICAL TRIAL MANAGEMENT

Project management
Study team set-up
Feasibility and site evaluation
Site identification
Operational set-up; e.g. plans, guidelines and manuals
Vendor selection and management
Site contract negotiations and management
Investigator and CRA meetings

● Target Product Profile development and training
● Regulatory Project management
● Regulatory Services
● Scientific advice (briefing book, study design, CMC, pre-clinical)
● Regulatory product strategy development
● Core Document development (protocol, IB, IMPD etc.)

Symbolization is an important definition for this perspective. Cultural perspective involves identity of symbols. The uses of words that are related with the image, the use of heroes in the image, etc. are the symbolization of the image.

The view of images in the critical perspective is when the viewers criticise the images, but the critics have been made in interests of the society, although an individual makes the critics.

START UP
PERIOD

MAINTENANCE PERIOD

CLOSURE AND REPORTING PERIOD

The view of images in the critical perspective is when the viewers criticise the images, but the critics have been made in interests of the society, although an individual makes the critics.

Pharmacovigilance

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● Site initiation and close out
● Study subject recruitment planning, follow-up and reporting, contingency planning and actions
● eTMF/TMF Management and quality control processes
● Safety management and reporting
● Medical monitoring through inhouse medical experts
● Training
● Data management
● Statistical involvement
● Quality assurance/quality control

● Final data cleaning and database lock
● Data sets
● Statistical programming and analysis
● Study report and submissions

START UP PERIOD

● Target Product Profile development and training
● Regulatory Project management
● Regulatory Services
● Scientific advice (briefing book, study design, CMC, pre-clinical)
● Regulatory product strategy development
● Core Document development (protocol, IB, IMPD etc.)

MAINTENANCE PERIOD

● Site initiation and close out
● Study subject recruitment planning, follow-up and reporting, contingency planning and actions
● eTMF/TMF Management and quality control processes
● Safety management and reporting
● Medical monitoring through inhouse medical experts
● Training
● Data management
● Statistical involvement
● Quality assurance/quality control

CLOSURE AND REPORTING PERIOD

● Final data cleaning and database lock
● Data sets
● Statistical programming and analysis
● Study report and submissions