Connect with Megalek about your upcoming clinical trial
Request a proposal
Connect with Megalek about your upcoming clinical trial
Request a proposal
Connect with Megalek about your upcoming clinical trial
Request a proposal
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Why Megalek
We will do our best for your study being successful
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.
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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