Evidence Based Consulting

Harvesting clinical data

Evidence-based consulting is the new "normal" in the healthcare industry. Better consulting is possible when you get your evidence right; therefore, tap in to the clinical data of patients. Clinical Data Management (CDM)—a pivotal area of clinical research; let Scientific Writing & Publishing lead the way.

EVIDENCE-BASED CONSULTING: SERVICES

1.Discuss procedures and specifications and prepare operating procedures

2.Prepare data base (DB) definition, data input standards, and other specifications

3.Clinical Trial Management System (CDMS) setup.

4.Data validation.

EVIDENCE-BASED CONSULTING: SERVICES

1. Case Report Form (CRF) copies and PDFs.

2. Data input, comparing and coding.

3. Logical and manual checks.

4. Prepare material for investigation and CRF lock (primary).

EVIDENCE-BASED CONSULTING: SERVICES

1. Matching Adverse Events (AE

2. Prepare case materials for case review.

3. Generate SAS data sets.

EVIDENCE-BASED CONSULTING: SERVICES

1. Generate Data Manatement (DM) log sheets.

2. Self inspection on completion--anually or on completion.

3. Record retention or archive management.

PANOPLY OF SERVICES

Your partner in Contract Research Outsourcing (CRO) services

Clinical Research Monitoring

Good Clinical Practice (GCP) guaranteed. Our highly trained Clinical Research Associates (CRA) ensure integrity of study and commitment to excellence—on par with ICH & GCP standards. Efficient monitoring of clinical sites from site qualification to report generation….

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Clinical Study Design

Your reliable CRO partner. Our experts in scientific, clinical, regulatory, and statistical study will design your clinical protocols and execute trials. Clinical study design and protocols that balance the interests of multiple stakeholders.…

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Global Regulatory Writing

Regulatory writing services for drugs and medical devices. We offer global regulatory and clinical writing services, and deliver clinical study protocols and findings with precision. Reports are scientifically accurate, culturally sensitive, and meticulously compliant with regulations and statutory bodies…

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Biostatistical Programming

Clinical biostatistics & statistical programming. Scientific Writing & Publishing provides direction to sponsors in design, conduct, analysis, and evaluation of clinical trials—on par with CDISC Standards. Extensive research, clinical and regulatory biostatistics services to meet your specific needs...

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Trial Patient Recruitment

Our patient recruitment team facilitates recruitment process based on your protocol, pre-screening conditions and inclusion/exclusion criteria. You pay only for the successful enrolment of patients thereby eliminating risk for sites and sponsors. We recruit patients for all clinical trials across the globe. This applies to all therapeutic areas as well...

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Navigating Regulatory Affairs (RA)

RA is another core area for clinical trials. Pharmaceutical firms need a constant update on country-specific regulatory and ethics requirements to be compliant with ever-changing legislation. Our team of RA experts advise legal and scientific restraints from a global perspective thereby helping you achieve your goals...

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SUBJECT-MATTER EXPERTS

SMEs in niche areas pen your papers

PATHOLOGY

PHARMACOLOGY

NEPHROLOGY

THERAPEUTICS

GENOMICS

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Hasten you projects through our experts.

Prolific writers across plethora of areas who know your subject and
industry.

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